Ostomy monitoring system and method

ABSTRACT

An ostomy bag can include one or more sensors for measuring one or more metrics. An ostomy wafer can also include one or more sensors for measuring one or more metrics. The sensors can be temperature sensors and/or capacitive sensors, for example, and the metrics can include bag fill, leakage, skin irritation, and phase of stoma output, among others.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND

Skin inflammation is a common symptom of irritated skin, caused, forexample, by exposure to UV radiation, ionizing radiation, allergens,chemical irritants, biological irritants or by mechanical trauma. Theprocess of such skin inflammation (also called “acute” inflammation) iscomplex and responds to help the skin fight infection. However, it isknown that when the skin is exposed to a triggering stimulus, such asradiation, an irritant or an allergen, blood flow to the site ofirritation is increased due to signaling of cytokines and chemokineswhich leads to vasodilatation of the cutaneous blood vessels, causingredness and an increase in skin temperature. As a result of the initialtriggering event, an amplified large inflammatory response is stimulatedthat, while designed to help the skin fight infection from invadingbacteria, actually causes considerable damage to the skin if leftuntreated.

SUMMARY

In some configurations, an ostomy wafer can include an adhesive layerconfigured to adhere to skin around a stoma of a living person; aflexible sensor layer coupled with the adhesive layer, the flexiblesensor layer comprising a plurality of temperature sensors; and aplurality of conductors wired to the plurality of temperature sensors,the plurality of conductors configured to be electrically coupled withan electronics hub so that signals from the plurality of temperaturesensors are electrically communicated to the electronics hub.

In some configurations, the ostomy wafer can further comprise a thirdlayer configured to cover the flexible sensor layer such that theflexible sensor layer is sandwiched between the adhesive layer and thethird layer.

In some configurations, the third layer can include an adhesiveconfigured to adhere to an ostomy bag.

In some configurations, the wafer can include a Tupperware clickmechanism for coupling with an ostomy bag.

In some configurations, the temperature sensors can be arranged inconcentric partial rings or concentric partial rings.

In some configurations, one or more of the concentric partial rings canbe severable so as to fit the ostomy wafer to different sized stomas.

In some configurations, the concentric partial rings can comprise two ormore rings. In some configurations, the concentric partial rings cancomprise two rings. In some configurations, the concentric partial ringscan comprise four rings.

In some configurations, the plurality of conductors can comprise aserpentine portion. In some configurations, the plurality of conductorscan comprise curved portions between the temperature sensors. In someconfigurations, the plurality of conductors can comprise half circleportions between the temperature sensors.

In some configurations, the plurality of temperature sensors can beelectrically connected in a matrix circuit.

In some configurations, the wafer can further include one or morecapacitive sensors.

In some configurations, the one or more capacitive sensors can bedisposed on the flexible sensor layer or a second flexible sensor layer.

In some configurations, the one or more capacitive sensors can beconfigured to detect moisture in adhesives of the adhesive layer.

In some configurations, the ostomy wafer can comprise a neck and a body.

In some configurations, a first temperature sensor of the plurality oftemperature sensors can be disposed on the neck as a reference sensor.

In some configurations, all other ones of the temperature sensors otherthan the first temperature sensor can be disposed on the body.

In some configurations, the conductors can be disposed in part on theneck.

In some configurations, the temperature sensors can comprise firsttemperature sensors disposed in a first region closer to a center of thebody and second temperature sensors disposed in a second region fartherfrom a center of the body.

In some configurations, the second temperature sensors can be used asreference temperature sensors.

In some configurations, the temperature sensors can be disposed in anapproximate menorah configuration.

In some configurations, the adhesive layer can comprise hydrocolloidadhesives.

In some configurations, the wafer can further include a border ringsurrounding the adhesive layer, the border ring comprising an adhesiveside configured to adhere to the skin around the stoma.

In some configurations, the adhesive side of the border ring cancomprise acrylic adhesives or hydrocolloid adhesives.

In some configurations, the adhesives on the border ring can be thinnerthan adhesives on the adhesive layer.

In some configurations, the border ring can have a greater outerdiameter than the adhesive layer.

In some configurations, the wafer can be used in combination with anostomy bag comprising a plurality of sensors.

In some configurations, an ostomy bag can include two walls joinedtogether along a seam around at least a portion of an edge of the ostomybag, a first one of the walls configured to be placed facing skin of auser and a second one of the walls configured to face away from the userwhen the first wall faces the skin of the user; an opening in the firstwall, the opening configured to be disposed around a stoma of the userand to receive effluent from the stoma; and one or more sensor layersdisposed in, on, or between one of the two walls of the ostomy bag, theone or more sensor layers comprising a plurality of temperature sensorsand a plurality of capacitive sensors, wherein the plurality oftemperature sensors can measure a temperature change due to the effluententering the bag, and wherein the plurality of capacitive sensors canmeasure a capacitance change due to the effluent entering the bag, theone or more sensors layer further comprising one or more wirelesscommunication antennas, wherein when in use, the one or more antennascan be in electrical communication with one or more antennas on anostomy wafer configured to couple the first one of the walls of theostomy bag to the skin of the user, and/or one or more antennas on a hubconfigured to be coupled to the ostomy bag on the second one of thewalls.

In some configurations, the capacitive sensors can be arranged in apattern of lines at non-90 degree angles with respect to one another.

In some configurations, the capacitive sensors can be configured todetect a fill level of the effluent in the bag when the bag is in anupright position and tilted.

In some configurations, the plurality of capacitive sensors can comprise12-48 capacitive sensors.

In some configurations, the plurality of temperature sensors cancomprise 20-64 temperature sensors.

In some configurations, an inner side of one or both of the two walls ofthe ostomy bag can be coated with a lubricating material.

In some configurations, the lubricating material can be hydrophilic orhydrophobic.

In some configurations, the coating can be done by spraying or dipping.

In some configurations, the coating can be effective throughout a lifecycle of the bag.

In some configurations, the plurality of temperature sensors and theplurality of capacitive sensors can be located on one sensor layer.

In some configurations, the bag can include comprising an electronicshub configured to receive signals from the temperature sensors orcapacitive sensors.

In some configurations, the electronics hub can comprise a wirelesstransmitter configured to transmit the signals to a user device.

In some configurations, the electronics hub can have an approximatelycrescent shape to aid weight distribution. In some configurations, theelectronics hub can have a substantially disc shape.

In some configurations, the electronics hub can comprise (1) a hardwareprocessor configured to convert the signals to temperature values and(2) a wireless transmitter configured to transmit the temperature valuesto a user device.

In some configurations, the electronics hub can include one or moreports, and optionally wherein the one or more ports are Universal SerialBus (USB) ports.

In some configurations, the electronics hub can be disposed in any ofthe following locations: on the second wall, in an approximate center ofthe second wall, at a top portion of the ostomy bag, or in a pocketformed in the first wall or the second wall.

In some configurations, the electronics hub can comprise a temperaturesensor configured to measure an ambient temperature.

In some configurations, the bag can include one or more of thefollowing: a capacitive sensor, a flex sensor, an odor sensor, amicrofluidic sensor, a camera, an infrared camera, an audio sensor, or agas sensor.

In some configurations, the temperature sensors can be thermistors or IRtemperature sensors.

In some configurations, the temperature sensors can be arranged in amatrix circuit.

In some configurations, the bag can include curved conductors connectingthe temperature sensors.

In some configurations, the bag can include a temperature sensors coverdisposed below the opening in the first wall.

In some configurations, a medical kit can include three groups of ostomybags of any of the preceding claims, a first group of ostomy bagscomprising diagnostic bag, a second group of ostomy bags comprisinganalytics bags, and a third group of ostomy bags comprising maintenancebags. In some configurations, the first, second, and third groups ofostomy bags can each comprise temperature sensors and capacitive sensorsconfigured to measure output volume, leak, and/or hydration status. Insome configurations, the first and second groups of ostomy bags can eachfurther comprise an optical sensor and the third group of ostomy bags donot include an optical sensor. In some configurations, the first groupof ostomy bags can further comprise a microfluidic sensor and the secondand third groups of ostomy bags do not include a microfluidic sensor.

In some configurations, an ostomy bag can include two walls joinedtogether along a seam around at least a portion of an edge of the ostomybag, a first one of the walls configured to be placed facing skin of auser and a second one of the walls configured to face away from the userwhen the first wall faces the skin of the user; an opening in the firstwall, the opening configured to be disposed around a stoma of the userand to receive effluent from the stoma; a sensor layer disposed in, on,or between one of the two walls of the ostomy bag, the sensor layercomprising a plurality of temperature sensors and a plurality ofcapacitive sensors, wherein the plurality of temperature sensors canmeasure a temperature change due to the effluent entering the bag, andwherein the plurality of capacitive sensors can measure a capacitancechange due to the effluent entering the bag, the sensor layer furthercomprising one or more wireless communication antennas, wherein when inuse, the one or more antennas are in electrical communication with oneor more antennas on an ostomy wafer configured to couple the first oneof the walls of the ostomy bag to the skin of the user, and/or one ormore antennas on a hub configured to be coupled to the ostomy bag on thesecond one of the walls; and an insulation layer disposed between thesensor layer and one of the two walls of the ostomy bag.

In some configurations, the insulation layer can be disposed between thesensor layer and each one of the two walls of the ostomy bag.

In some configurations, the insulation layer can comprise a foam or afibrous material.

In some configurations, the bag can include the insulation layercomprises polyester or polyurethane.

In some configurations, the bag can include the insulation layer isconfigured to insulate the plurality of temperature sensors from heatfrom the user's body.

In some configurations, the bag can include the insulation layer isconfigured to insulate the plurality of temperature sensors or theplurality of capacitive sensors from ambient signal noises.

In some configurations, a method of detecting an ostomy leak can includeunder control of a hardware processor, sensing temperature readings of atemperature sensor disposed in an ostomy wafer; detecting a rapid changein the sensed temperature occurring within a threshold time; andoutputting an indicating that a leak has occurred at a location in theostomy wafer corresponding with the temperature sensor.

In some configurations, the sensing and detecting can comprisetemperature readings with a plurality of temperature sensors disposedabout the ostomy wafer.

In some configurations, the plurality of temperature sensors can bedisposed in one or more rings or partial rings.

In some configurations, the method can further include measuringcapacitance values of a plurality of capacitive sensors disposed on thewafer.

In some configurations, the method can further include determining amoisture content of adhesives on a user-facing adhesive layer of thewafer, wherein a decrease in the moisture content is indicative of thewafer becoming loose.

In some configurations, the temperate readings can be presented as aheat map.

In some configurations, the method can be implanted with any of thefeatures of an ostomy device disclosed herein.

In some configurations, a method of detecting skin irritation around astoma can include under control of a hardware processor, sensing a firstgroup of temperature readings of a first plurality of temperaturesensors disposed about an ostomy wafer; sensing a second group oftemperature readings of a second plurality of temperature sensorsdisposed about an ostomy wafer, the second plurality of temperaturesensors located further away from the stoma than the first plurality oftemperature sensors; detecting a difference in the temperature of thefirst and second groups of temperature readings, the first group oftemperature readings being greater than the second group of temperaturereadings; and outputting an indicating that irritation has occurred ator near the stoma.

In some configurations, the temperate readings can be presented as aheat map.

In some configurations, the plurality of temperature sensors can bedisposed in a matrix in the ostomy wafer.

In some configurations, the detecting can be performed using acomparator.

In some configurations, the hardware processor can be further configuredto consider the temperature change to correspond to effluent but toreject a change in the second group of temperature readings that doesnot correspond to temperature changes flowing from the first pluralityof temperature sensors to the second plurality of temperature sensors.

In some configurations, the hardware processor can be further configuredto reject a change in the second group of temperature readings that isbelow a threshold rate.

In some configurations, the hardware processor can be further configuredto calibrate based on detecting body temperature prior to flow of theeffluent.

In some configurations, the hardware processor can be further configuredto detect a phase of the effluent based on a speed of the change intemperature readings.

In some configurations, the hardware processor can be further configuredto cause temperature readings changes that are due to gas to be ignored.

In some configurations, the method can be implanted with any of thefeatures of an ostomy device disclosed herein.

In some configurations, a method of detecting fill of an ostomy bag caninclude under control of a hardware processor, sensing capacitancevalues of a plurality of capacitive sensors disposed in an ostomy bag;calculating a level of the fill of the bag based at least in part on thecapacitance values; and outputting an indicating that a volume of bagfill has increased responsive to detecting change in the capacitancevalues.

In some configurations, the calculating can be performed by machinelearning.

In some configurations, the calculating can be performed by a trainedneural network model.

In some configurations, the method can further include sensingtemperature values with a plurality of temperature sensors disposed inthe ostomy bag, wherein the calculating is based in part on thetemperature values.

In some configurations, the method can further include creating aplurality of event flags, wherein the plurality of event flags cancomprise detection of infusion, detection of drain, and detection of thebag on a user.

In some configurations, the detection of infusion can be based onreadings from temperature sensors located near an opening of the bagconfigured to be disposed over a user's stoma.

In some configurations, infusion can be detected when the readings fromthe temperature sensors located near the opening of the bag exceed aninfusion criteria.

In some configurations, the calculating can be performed upon infusionbeing detected.

In some configurations, the detection of drain can be based on readingsfrom temperature and/or capacitive sensors located near a bottom of theostomy bag.

In some configurations, drain can be detected when the readings from thetemperature and/or capacitive located near the bottom of the ostomy bagexceed a drain criteria.

In some configurations, the detection of the bag on the user can bebased on the temperature sensors located near an opening of the bagconfigured to be disposed over a user's stoma.

In some configurations, the method can further include calibrating thecapacitive sensors upon one or more of: detecting the drain, ordetecting the bag on the user and first readings from the capacitivesensors have been taken.

In some configurations, the method can further include smoothing spikesin raw volume calculations.

In some configurations, the method can further include causing to bedisplayed on a user device in electrical communication with the bag oneor more of: a volume of bag fill, a restroom location, or a hydrationtracker.

In some configurations, the method can further include detecting phasingof effluent in an ostomy bag under control of a hardware processor bysensing temperature values of a plurality of temperature sensorsdisposed in an ostomy bag, the plurality of temperature sensors being incontact with the output; and determining a phase of the effluent basedin part on the temperature values.

In some configurations, the hardware processor can be further configuredto detect a phase of the effluent based on a speed of the change intemperature.

In some configurations, the hardware processor can be further configuredto cause temperature value changes that are due to gas to be ignored.

In some configurations, a heavier thermal print on the heat map canindicate a more viscous effluent.

In some configurations, the trained neural network model can beconfigured to recognize borders between effluents of different phases onthe heat map.

In some configurations, the hardware processor can be further configuredto subtract a volume of effluent due to gas from a volume calculationbased on the fill detection.

For purposes of summarizing the disclosure, certain aspects, advantagesand novel features of several embodiments have been described herein. Itis to be understood that not necessarily all such advantages can beachieved in accordance with any particular embodiment of the embodimentsdisclosed herein. Thus, the embodiments disclosed herein can be embodiedor carried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheradvantages as taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

FIG. 1A illustrates schematically prior art example ostomy bags.

FIGS. 1B and 1C illustrate schematic overviews of example ostomymonitoring environment according to the present disclosure.

FIG. 2 shows an example sensor layer of an ostomy wafer.

FIG. 3 shows another example sensor layer of an ostomy wafer.

FIG. 4 shows example layers of an ostomy wafer.

FIG. 5 shows another example of a sensor layer that may be included inan ostomy wafer.

FIG. 6 shows an example implementation of the sensor layer of FIG. 5.

FIG. 7 shows an example circuit schematic of a sensor layer that may beincluded in an ostomy wafer.

FIG. 8 shows example sensors on or in an ostomy bag

FIG. 9 shows an example ostomy bag with a sensor layer.

FIG. 10 shows a front view of an example sensor layer of an ostomy bag.

FIG. 11 shows an example back view (user contact side) of an examplesensor layer of an ostomy bag.

FIG. 12 shows example wiring of a sensor layer of an ostomy bag.

FIG. 13 shows an example ostomy bag with a sensor layer connected to anostomy wafer layer.

FIG. 14A shows the layered ostomy wafer of FIG. 4 placed on an exampleostomy bag.

FIG. 14B shows an example ostomy bag with layers of sensors that facesaway from the user.

FIG. 14C shows a side view of layers of an example ostomy bag having aninsulation layer.

FIG. 14D shows an example ostomy bag with a pocket for an electronichub.

FIGS. 15A-15G illustrate an example ostomy wafer attached to exampleostomy bags with different example electronics hub placements.

FIG. 16 shows an example heat map that represents the heat signature ofa thermistor layer of an ostomy wafer.

FIG. 17 shows an example ostomy bag leak detection process.

FIG. 18A shows an example device worn by a patient.

FIG. 18B shows an example heat map showing a stoma discharge flow in thedevice of FIG. 18A.

FIGS. 19A-19F show an infusion of applesauce at different volumes in astanding position.

FIGS. 20A-20G show an infusion of water in a standing position atvarious volumes from 50 mL up to 350 mL at 50 mL increments.

FIG. 21 shows an example ostomy bag fill detection process.

FIG. 22 shows an example user interface for a “Status Screen” of apatient application in electrical communication with an electronic hubof an ostomy bag.

FIG. 23 shows an example alarm user interface of the patientapplication.

FIG. 24 shows an example user interface of a hydration tracker feedbackfeature of the patient application.

FIG. 25 show a user interface of an example hydration progress screen ofthe patient application.

FIG. 26A shows an example of an additional user interface of a restroomlocator feature of the patient application.

FIGS. 26B-26C show examples of a user interface illustrating output andrestroom location feature of the patient.

FIG. 26D illustrates an example user interface illustrating additionalinformation relating to output.

FIG. 26E illustrates an example user interface illustrating anapplication overview display page.

FIG. 27 illustrates an example test setup of an ostomy bag on ananatomical model using a thermal imaging camera.

FIG. 28 depicts an example thermal image of a patient's stoma using atest thermal imaging camera.

FIGS. 29A-29D depict example thermal images of apple sauce infusion ofthe ostomy bag of FIG. 27.

FIGS. 30A-30D depict example thermal images of oatmeal infusion of theostomy bag of FIG. 27.

FIGS. 31A-31D depict example thermal images of mashed potatoes infusionof the ostomy bag of FIG. 27.

FIG. 32 illustrates schematically temperature sensors on an examplesensor layer of an ostomy wafer.

FIGS. 33A-33B illustrate top and bottom views of the sensor layer ofFIG. 32.

FIG. 34A illustrates a top view of the example sensor layer of an ostomywafer.

FIG. 34B illustrates a perspective view of the sensor layer of FIG. 34A.

FIG. 34C illustrates a side view of the sensor layer of FIG. 34A.

FIG. 35A illustrates an example schematic circuit diagram of a waferPCB.

FIG. 35B illustrates an example schematic circuit diagram of temperaturesensors on a sensor layer of an ostomy wafer.

FIG. 35C illustrates an example schematic circuit diagram of a batteryon a sensor layer of an ostomy wafer.

FIG. 36 illustrates schematically temperature sensors on an examplesensor layer of an ostomy bag.

FIG. 37 illustrates schematically capacitive sensors on an examplesensor layer of an ostomy bag.

FIG. 38 illustrates schematically temperature and capacitive sensors onan example sensor layer of an ostomy bag.

FIGS. 39A-39B illustrates examples of sensor layers of an ostomy bag.

FIGS. 40A-40B illustrate top and bottom views of the sensor layer ofFIG. 39A.

FIG. 41A illustrate a top view of the sensor layer of FIG. 39B.

FIG. 41B illustrate a perspective view of the sensor layer of FIG. 39B.

FIG. 41C illustrate a side view of the sensor layer of FIG. 39B.

FIG. 42A illustrates an example schematic circuit diagram of a bag PCB.

FIG. 42B illustrates an example schematic circuit diagram of temperaturesensors on a sensor layer of an ostomy bag.

FIG. 42C illustrates an example schematic circuit diagram of capacitivesensors on a sensor layer of an ostomy bag.

FIG. 42D illustrates an example schematic circuit diagram of a batteryon a sensor layer of an ostomy bag.

FIG. 43 shows another example ostomy bag fill determination process.

FIGS. 44A-44B illustrate example top and bottom views of an electronichub of an ostomy bag.

FIG. 45 illustrates the hub of FIGS. 44A-44B coupled to an ostomy bag.

FIGS. 46A-46D illustrate front, back, bottom, and perspective views ofanother example electronic hub of an ostomy bag.

FIG. 46E illustrates an exploded view of the electronic hub of FIGS.46A-46D.

FIG. 47A illustrates schematically a plurality of capacitive sensors onan example ostomy bag.

FIG. 47B illustrates schematically a plurality of temperature sensors onan example ostomy bag.

FIG. 48 illustrates schematically an example neural network model forcalculating output volume of an ostomy bag.

FIG. 49A illustrates example readings of capacitive sensors on an ostomybag after first measurement.

FIG. 49B illustrates example readings of capacitive sensors on an ostomybag after draining of the bag.

FIG. 50 illustrates example algorithm logics for detecting infusion,drain, and output of an ostomy bag using capacitive and temperaturesensors.

DETAILED DESCRIPTION

Introduction

Systems and examples described herein relate to systems and methods fordetecting skin inflammation, for example, for detecting skininflammation around a wound. Systems and examples also relate to anostomy system for detecting peristomal skin inflammation due, forexample, to leakage at the ostomy site.

For skin wounds, such as post-operative surgical wounds, skininflammation can also be the first indication of infection. Sinceinfected wounds can have serious local and systemic complications for apatient, fast detection and treatment of infection is paramount. Oftenhowever, patients fail to recognize the first signs of skin inflammationand can become unwell before seeking medical advice.

Stoma patients, in particular, are at risk of suffering skininflammation from both irritation and infection. Any leakage of wasteleaving the body through the stoma (for example, the “stomal output”)onto the peristomal skin can lead to irritant dermatitis, fungalinfections, fungal dermatitis or folliculitis. In addition, the wearingof an ostomy device can cause irritation to the skin on the outside ofthe abdomen wall due to mechanical trauma resulting from an ill-fittingappliance and/or from the constant removal and re-attachment of theostomy device.

This disclosure describes examples of systems and methods for detectingskin inflammation around a stoma, as well as leakage around the stoma.The systems and methods can be used in the context of an ostomy systemfor detecting peristomal skin inflammation of colostomies, ileostomies,urostomies, and the like. One example system can include an ostomy waferthat includes one or more sensors that provide outputs responsive toskin inflammation and/or leakage. The sensors can be temperaturesensors, capacitive sensor(s), or other types of sensors, many examplesof which are discussed in detail below.

An increase in temperature output by temperature sensors in the ostomywafer can correspond with effluent leaking onto the peristomal skin (forexample, leaking under the ostomy wafer). An increase in temperatureoutput by the temperature sensors can also correspond with an increasein skin irritation due to the effluent leakage. Thus, the system candetect changes in temperature that may be indicative of effluent leakageand/or possible skin irritation, prior to a user noticing leakage orskin irritation. The system can output an indication to a user based on,among other things, the detected temperature changes. The indication mayinclude an audible and/or visual representation of the changes intemperature, a warning, alert, or alarm regarding impending or detectingskin irritation. As will be described in greater detail below,capacitive sensors may be used on the wafer instead of and/or inaddition to temperature sensors to detect the presence of moisture.

Another problem facing ostomy patients is leakage at the ostomy site,for example, due to overfilling of the ostomy bag. It can be difficultfor some users to detect when an ostomy bag is full. This isparticularly the case because an ostomy bag typically reaches itsdesigned capacity before it appears full to a user. The designedcapacity of an ostomy bag may be less than its apparent capacity toavoid leakage back into the stoma. In addition, a user may forget tocheck the ostomy bag and thus may accidentally permit the bag tooverflow. Leakage can be uncomfortable, embarrassing, and damaging toclothing and skin, creating the irritation discussed above.

This disclosure also describes systems and methods for detecting ostomybag fill. One example system includes an ostomy bag that includes one ormore sensors for detecting bag fill. The one or more sensors can includetemperature sensors. The temperature sensors can output temperaturemeasurements indicative of changes in temperature responsive to effluententering the ostomy bag. The system can output an indication to a userbased on the detected temperature changes. The indication may include anaudible and/or visual representation of the changes in temperature, awarning, alert, or alarm.

The system can also include one or more volumetric sensors (for example,capacitive sensors, or others). The system can output an indication toempty and/or change the bag to a user based on, for example, detectedcapacitance changes in one or more capacitive sensors, which can be onthe ostomy bag. For example, a capacitive sensor can include anelectrode in electrical communication with a capacitive sensor chip formonitoring the capacitance of the electrode.

The ostomy wafer described above may be used together with the ostomybag described above. The ostomy wafer may also be integrated togetherwith the ostomy bag. Further, an example system may also include one ormore wireless transmitters that transmit data from the ostomy waferand/or ostomy bag to another device, such as a hub, a user device, aclinician device, and/or a back-end system. For example, the ostomywafer and/or the ostomy bag can wirelessly transmit data to a hubcoupled to the ostomy bag, and the hub can transmit the received data toa back-end system (such as cloud servers). A user device (for example, asmartphone or tablet) can download the data and other information fromthe remote server.

This disclosure also describes many other example sensors, parametersthat may be detected using those sensors, and variations of ostomywafers and ostomy bags.

Overview

This section provides a detailed overview of various problems affectingostomy patients as well as an overview of some of the solutions providedby this disclosure. More detailed example features are described belowwith respect to the drawings, starting under the heading entitled“Example Ostomy Monitoring System.”

An ostomy bag can be a medical bag that collects human waste (eitherstools, urine, or both) from patients who cannot excrete waste naturallydue to medical issues, which include, among others, cancer, trauma,inflammatory bowel disease (IBD), bowel obstruction, infection and fecalincontinence. In such cases, a surgical procedure is performed whereby awaste passage is created. This waste passage can be the ureter (calledan urostomy), the small bowel or ileum (called an ileostomy, part of thesmall intestine) or the large bowl or colon (called a colostomy, part ofthe large intestine), which may be diverted to an artificial opening inthe abdominal wall, thus resulting in part of the specific internalanatomy, to lie partially outside the body wall. This procedure can bereferred to as an ostomy, and the part of the waste passage which isseen on the outside of the body can be referred to as a stoma.

A prior art image of example ostomy bags is presented in FIG. 1A. InFIG. 1A, two ostomy bags are shown. These bags include a one-piece bagto the left and a two-piece bag to the right. The one-piece bag (on theleft) has a baseplate (also sometimes referred to as a faceplate orcalled an ostomy wafer or simply wafer) already attached and integratedonto the bag. The two-piece bag has a separate wafer and bag (and thusincludes an attachment or flange). In the case of the one-piece bag, itis usable only once, and when it is time to change the bag, the fullappliance needs to be disposed. In the case of the two-piece bag, thebag can be disposed without having to take off the wafer. Some peopleprefer this two-piece set-up, leaving the wafer on their bodies whileremoving only the bag, as removal of the wafer (which may contain ahigh-tac adhesive) can be a form of mechanical strain on the skin, whichsome prefer to avoid. When the bag is worn on the user, the wafer sidein the one-piece bag, or the wafer-interfacing side of the two-piecebag, can face the user's body. The wafer can sit around the stoma (thus,the stoma sits in a stoma hole in the wafer) and can be made from abiocompatible hydrocolloid or hydrocolloid adhesive-based material,which are both skin friendly and so can stick to the skin easily oncethe stoma is in place through the stoma hole. Many other example waferand bag materials are described in greater detail below. Both diagramsare examples of drainable bags, in that they have vents at the bottom ofthe bag for the patient to remove the waste when it is time to emptytheir bags. Some bags do not have a vent and so cannot be drained. Thus,when full, such bags are disposed without the function to be able todrain them. The average wear time of an ostomy bag/pouch can be 1-3 daysor 3-5 days. The average wear time of a baseplate can be about 3-5 days.

The type of waste released by patients with the three different forms ofostomies (urostomy, ileostomy, and colostomy) can be different. Urostomywaste includes urine, ileostomy waste can include stools ofporridge-like consistency, and waste from colostomy patients can includefirm stools. The size of the stoma that is created by the stoma surgeonmay be determined by the specific type of ostomy that the patient has.For example, a colostomy is the divergence of the colon (largeintestine) to the opening in the abdominal wall and hence the stoma size(for example, the diameter) may be expected to be quite large. This isin contrast to an ileostomy patient, who would have his/her ileum (partof the small intestine) diverted to an opening in the abdominal wall.Because of the smaller size of the small intestine, the stoma size islikely to be smaller.

Currently bags in the medical bag industry (which includes ostomy bags,blood bags, saline bags, catheters, etc.) function solely as plastic bagtype collection vessels which can be emptied and re-used, or disposedand replaced by a new one. Other than that, they have no advancedfunctionality or uses, for example clinical diagnostic capabilities.Thus, for example, analytical urine and stool tests are currentlyconducted in a lab facility by the physical collection of samples fromthe patient, which are subsequently sent to various diagnostic labs forclinical laboratory analysis.

This disclosure describes several different example bags and wafers thatcan include sensors and optionally electronics. The electronics on thebags and/or wafers can perform a significant amount of analyticalanalysis (for example, calculation of at least some of the leak and/orskin irritation detection metrics disclosed herein). The sensors andelectronics on the bag and/or wafer can transmit sensor signals (whichcan be unprocessed and/or minimally processed or conditioned signals) toa back-end system (such as cloud servers) for calculation of the metrics(for example, the temperature and/or capacitance change). With systemsincorporating such bags and wafers, the measurement of other metrics canbe done within the bag itself (optionally together with an externaldevice such as a patient's phone), without the need for third partyintervention, such as a lab, to conduct the analysis. Thus, thisdisclosure describes some examples of a “lab on a bag.” The bag caneffectively be able to give each patient as well as his/her physicianand/or nurse and/or caretaker, in-situ patient clinical information.

An example of such clinical information can be electrolyte levels suchas sodium (Na+), calcium (Ca2+), or potassium (K+) levels, the loss ofwhich can be indicative of patient hydration levels as well as acting asmarkers for diabetes, renal and liver dysfunction as well as cardiac andother diseases. Another clinical marker that may be used on bags hereinis the pH level, for example in urine, which can give indication of UTls(Urinary Tract Infections) as well as ketosis and severe diarrhea. Othertypes of substances in the output can be monitored, such as presence ofdrugs.

Other metrics can be of incredible value to both the patient and his/hermedical team in charge, as well as possible care giver. In response tothis, the bag and/or wafer can also measure the physical informationassociated with events which occur on a daily basis in the lives ofostomy patients. This physical information can encompass data on thefullness of the bag as well as monitoring the volume of output in theostomy bag, the flow rate in the effluent/output, its physical phase andthe viscosity of the effluent, and finally peristomal skin irritationand leakage of the effluent, both around the site of the stoma and inthe hydrocolloid wafer. A brief overview of examples of these metricsfollows.

Bag Fill and Volumetric Measure:

Data and indicators regarding the fullness of the bag can be usefulmetrics for patients, providing early indication that his/her bag needsto be emptied, which can prevent the patient from potentiallyunfortunate and embarrassing incidents such as overfilling of the bagand can prevent the effluent from contacting the skin around the stomasite thus causing irritation or infection. Such incidences can impactpatients socially and psychologically. Further, volumetric output canhave a strong correlation to the patient in terms of their diet andhydration and therefore can be a good indirect indicator of thefunctionality of the GI (Gastro Intestinal) system and its ability toabsorb nutritious components such as vitamins, proteins, glucose,minerals, and the like whilst being indicative of its throughput inremoving the waste from the patient's body. Thus, a quantitative measureof the volumetric output from the stoma can indirectly give clinicalguidance of the functioning of the GI system.

However, the output of each patient can be a very subjective metric,with some patients having significantly more output and otherssignificantly less. Linearity may not always be the case in therelationship between input and output, with some patients havingsignificant output in comparison to what is going into their bodies.Thus, the combined information of the input of the patients with theiroutput, could lead to early signs of for example dehydration (forexample, by losing significantly more water through the measured outputthan that which is going into the body via fluid intake).

A mobile application and/or web site can be provided to patients, whichcan include a platform of different trackers such as food and hydrationtrackers. With the application optionally being able to record metricssuch as diet and hydration (via user interaction and trackers within theapp) and the bag sensor(s) able to indicate the volume in the bag, thisintegrated platform can work together to give early signs ofdehydration, dietary issues or even GI dysfunction in patients.Dehydration can be a significant metric because it is one of the mostcommon reasons why patients are readmitted into the hospital in thefirst three months following ostomy surgery. Thus, providing featuresthat can help patients become aware of their output can enable patientsto better monitor and prevent dehydration, significantly improvingquality of care and life while at the same time potentially reducing thepost-operative costs associated in hospital re-admissions followinginitial stoma surgery.

Flow Rate, the Physical Phase and the Viscosity of the Effluent:

Knowledge of the physical phase (including solid, semi-solid, liquid,and gas) of the effluent that is coming out of the bag can be clinicallysignificant. In the case of urostomates and colostomates, the phase ofthe output can be generally fixed for both groups of patients, with theoutput being of liquid and solid phases, respectively. However, in thecase of ileostomy patients, the output may be of porridge-likeconsistency, meaning it can be a mix of solid, liquid, or semi-solid.Moreover, both colostomy and ileostomy patients may have gas in theoutput. The knowledge of the phase of the output can give early signs ofdehydration, functionality of the GI tract of the patient, andinformation about the lifestyle of the patients such as their dietaryhabits or hydration habits. Combined with the mobile applicationdiscussed above, clinically significant data and events can bedetermined and relayed to doctors rapidly. Moreover, detection of gasoutput can enable a more accurate calculation of bag fill, as discussedbelow in more detail.

Skin Irritation and Leakage of the Effluent Around the Stoma:

Leakage as a phenomenon, is particularly common with patients who havemore fluid-like output, but can also occur with colostomy patients whohave more firm output, through so-called “pancaking” of the stool aroundthe stoma. Leakage can occur when the effluent/output of the patientdoes not entirely enter the bag. Instead, some of it bypasses the bagand starts to accumulate between the adhesive side of the wafer(skin-side facing) and the skin surrounding the stoma (also called theperistomal skin, which lies behind the wafer). The output encompassesbiological and chemical enzymes, which when in contact with the skin forlong periods of time, and as a function of their accumulation, can startto “erode” and thus irritate and scar the skin. The method by which skinis irritated in this scenario can be called Irritant Contact Dermatitis(ICD) or Incontinence Associated Dermatitis (IAD). For ease ofdescription, this specification often refers to ICD and IADinterchangeably.

Leakage can be caused by a number of reasons, with some of the mainreasons being the loss of tackiness of the hydrocolloid adhesive as afunction of long wear times or sweat and/or moisture accumulationbetween the wafer and the skin behind it. The accumulation of thisenzymatic output, behind the wafer, can also promote erosion of and candestroy the hydrocolloid. In doing so, this erosion can break down theadhesive too, destroying its tackiness and therefore ultimately makingit redundant. Long wear times are very common with ostomy bags, with 3-5days being the average wear time per patient before disposal to utilizea new bag. Thus, it can be imagined that over this long period ofcontinuous wear, the hydrocolloid is likely to be exposed to significantamount of moisture, resulting in its ultimate inability to be utilizedwithout leaking.

Moisture and sweat can also act as catalysts to exacerbate the symptomsof leakage because as these forms of moisture start to saturate thehydrocolloid, which has a maximum saturation limit, beyond which itcannot absorb further moisture, then they effectively prevent thehydrocolloid from absorbing the leaking effluent. As a result, theleaking effluent accumulates in between the peristomal skin and the backof the wafer, causing ICD.

ICD is a major concern and issue with a large number of patients, but sofar the interventions made by the major bag companies to prevent leakageand subsequently skin irritation, include the utilization of productssuch Eakin seals which limit the leakage or wipes that form a protectivebarrier that protect the skin from damage of the adhesive, effluent andenzymes or integration of components like ceramide into the barrier tomaintain good skin health and maintain good peristomal skin health.Despite these interventions, many patients are still struggling withperistomal skin complications. One disadvantage that patients face isthe lack of sensation of the leakage occurrence. By the time the patientrealizes that leakage has occurred, it can become too late because theactive enzymes species may have already done significant damage to theirperistomal skin. The skin irritation that occurs can be on multiplelevels, which WOCNs (Wound Ostomy Care Nurses) can assess via the DET(Discoloration, Erosion and Tissue Overgrowth) score. This scoringsystem is described as an ostomy skin tool utilized by nurses as astandardized way of assessing the peristomal skin conditions andcomplications in ostomy patients. This scoring tool is scored for skinirritation promoted by chemical irritation which encapsulates IAD orICD, mechanical trauma (due to frequent change of the bag wafer),disease related irritation and infection related irritation, as seen inthe previous citation. The infection around the stoma can be a symptomof the initial skin irritation coupled with moisture and the presence ofsweat.

As yet, based on inventor knowledge, there has been no commercialinterventions to provide a technological solution which can indicate thein-situ occurrence of leakage or the saturation and/or breakdown of thehydrocolloid or potential skin irritation at an early stage. However,example devices and algorithms described herein can give users a warningto change their flange/wafer and thus take preventative action tominimize their skin conditions worsening.

Further, there has been no commercial technological solution, based oninventor knowledge, for the detection of the volume in the bag,assimilation of the physical phase in the bag and the flow rate, wheretemperature is being used as a marker. Solutions to be able to detectthese metrics from a technological perspective, with an overall motiveto communicate this information (for example, in real-time) to a varietyof different stakeholders (for example, patients, nurses, doctors, caregivers, care takers) via a smart phone or smart tablet platform asillustrated further below, would be of great value to the healthcare andpatient communities.

An example smart ostomy bag (or “smart bag”), which can also encompass awafer, can have integrated sensors that can track one or more in-situphysical events inside the bag. These events can include volumetricanalysis, flow rate, physical phase of the effluent, viscosity of theeffluent, possible skin irritation, and/or leakage occurrence around thestoma and saturation of the hydrocolloid. The smart bag can also trackmore detailed clinical/analytical metrics of the bag such aselectrolytic measurements, pH, and other markers, which be explained infurther detail below.

One physical marker that can allow for the detection of some or all ofthe metrics described above is heat/temperature. The following sectionwill explain why heat can be a relevant marker in order to detect one ormore metrics of interest.

As mentioned previously, peristomal skin irritation is one of thetop-ranked complications for ostomy patients, which can be caused byfrequent change of the wafer, allergy, folliculitis, or leakage of theskin barrier/wafer (a leakage can occur when the stoma output seepsbetween the skin and the skin barrier/wafer, which may eventually extendoutside of the skin barrier/wafer).

Despite the variety of factors that cause ICD, which can collectively betermed irritants, each of these factors can lead to an increasedsubcutaneous blood flow, and resultantly, an increased skin surfacetemperature. Though specific clinical data on peristomal skintemperature is not available in literature, other studies on chronicwounds and ulcers have shown evidence of a 3-4° C. difference in skintemperature between the irritated skin and the contralateral unaffectedreference skin irritation. Therefore, the in-situ monitoring of theperistomal region skin surface temperature, as well as a region furtheraway from this periphery (in order to have an un-irritated referencearea of measure), can provide information about the skin health and canindicate early signs of skin irritation.

Since stoma output can be associated, at least initially as the outputleaves the stoma, with internal body temperatures (at or about 37° C.)which is higher than the external skin temperature (specifically theabdominal skin surface) (about 32-35° C.), temperature can also beutilized as a marker to warn of leakage occurrence behind the skinbarrier/wafer and therefore to alert the on-coming of early-stageperistomal skin irritation. When the leakage occurs, it would beexpected that the temperature in the wafer may increase veryrapidly—even appearing to be an instantaneous increase. This rapid orinstantaneous temperature change can be monitored as a function of theleakage occurrence to detect the leakage in-situ.

The wafer of the ostomy bag made with hydrocolloid-based materials canhave advantages including but not limited to: 1) it adheres to the skinsurrounding the stoma, whether it is moist or a dry skin site, 2) in thecase of wound exudates, which are a very common occurrence in ostomyapplications, the hydrocolloid dressing absorbs fluids and swells,protecting the wound, causing less pain and faster healing and 3) giventhat in ostomy applications most bags are commonly changed after about a1-1½ day, 1-3 day, or 3-5 day period in the USA (commonly about 1-2 daysin the UK), and the baseplates being changes after about every 5-6 days,the wear life of the hydrocolloid dressing can be sufficiently long suchthat, once worn, the dressing needs not be replaced in between bagchanges, causing less disruption to the wound.

Given that the hydrocolloid absorbs exudates as well as moisture fromthe body, for example sweat, it is expected that it will expand as afunction of the absorption of the fluids. The expansion of thehydrocolloid as a function of the absorption is suggestive of a changein temperature between the hydrocolloid adhesive and the peristomalregion as the hydrocolloid effectively moves away from the skin as afunction of the exudate absorption. Therefore, the route to detect thesaturation of the hydrocolloid, can be via detecting the temperaturechange as a function of time, which can give early indication of thesaturation of the hydrocolloid. This can be important as many patientsdo not have the sensation of leakage or of the hydrocolloid saturatinguntil they can visually see or feel the flange detach off their bodies,which occurs naturally as a function of the reduced tackiness of thehydrocolloid adhesive.

Apart from temperature, another useful marker for detecting one or moremetrics of interest, via the wafer or bag, can be the pH. The pH can beuseful due to the leakage occurrence of the exudate and its contributionto the saturation of the hydrocolloid wafer. Given that the effluentcontains enzymes of a biological and chemical nature, and the fact thatthey are able to erode the hydrocolloid and cause chemical damage to theskin, is suggestive an acidic or alkali nature of the effluent.Essentially the skin chemistry as well as the nature of the hydrocolloidwafer is changing as a function of the chemical and/or biologicalattack. By detecting the change in pH of the hydrocolloid as a functionof the leakage occurrence, or its saturation and/or alternativelydetecting the pH of the skin as a function of the enzymatic attack, apowerful combination of sensors (temperature and pH) can give earlyindication of leakage/skin irritation/saturation of the hydrocolloidwafer. By embedding (for example) a thread-based microfluidic pH sensorinto the wafer, oversaturation and leakage can be detected. Of course,pH monitoring is optional.

Heat/temperature as an example marker for measuring metrics from thefront (and potentially the back) of the main body of the bag will bedescribed in greater detail below.

Some ostomy bag can include a volumetric sensor, based on a resistiveflex sensor, which can measure the volumetric fill in bags and warn thepatients for the draining points (for example, the times to empty theirpouches). The nature of the flex sensor causes it to suffer from noisebecause of patients' natural movements (sitting, standing sleeping,running) and movements of the content within the ostomy bag.

As mentioned above, effluent is likely to be initially at internal humanbody temperature (at or about 37° C.) which is higher than the externalskin (specifically the abdominal skin surface) temperature (about 32-35°C.). Therefore, the utilization of heat/temperature as a marker tounderstand the volumetric fill in the bag can be used to determine thevolume in the bag. The effluent is likely to be the warmest when itexits the stoma, and as it travels from the top of the bag to the bottomof the bag where it settles, it may gradually cool down. The movement ofthe effluent from the top of the bag to the bottom of the bag, as welloptionally as the possible settlement of effluent, can be heat mappedand thus be indicative of the volume in the bag. 2D or 3D heat mappingof the bag can be used to understand the volumetric activity in the bag.

Temperature measurements can permit visualizing the thermal signaturesand heat patterns across the front and/or back of the bag, as theeffluent enters the bag. The thermal signatures of the effluent cantherefore be traced from the point where the effluent enters the bag tothe point where it settles. Given that the output can be of differentphysical forms depending on the type of ostomy a patient has, such asurostomy (fluid-urine), colostomy (firm stool-solid) and ileostomy(porridge like output semi-solid/solid-liquid), the flow rate can bevisually mapped by understanding the rate at which an array of thermalsensors is fired up, as the effluent crosses their path whilst heat isevolving/dissipating from the waste at the same time.

Heat dissipation, or more specifically rate of the heat dissipation, andcooling, can vary between the different physical phases, as can the flowrate. The rate of heat dissipated can depend on the heat capacities ofthe different phases as well as if the waste is in motion or stagnant.The flow of each phase can depend on the viscosity, with the liquidurine samples likely to be less viscous as the particles in liquid areto some extent free-flowing, allowing this phase to flow and travelquickly into the bag, and cross the path of the thermal sensors veryfast. In the case of solid waste, the flow rate can be significantlyslower due to the less free-flowing particles in the phase, and hencewhere an array of temperature sensors would be present, this phase islikely to cross the path of the thermal sensors more slowly. Therefore,it is possible to tell from the rate at which essentially an array ofthermal sensors fires up—for example, the sensors' response time to therate of movement of the effluent whilst it is entering the bag atinternal body temperature and crossing the path of the array of thermalsensors—the viscosity and therefore the phase of the effluent. Thetimeframe of how long the thermal signature of the volumetric outputlasts can also allow for indirectly determining the viscosity and phaseof the effluent (such as liquid, solid, semi-solid, and gas). It wouldbe expected (depending on the rate of heat dissipation) that thetemperature of the output may drop back to baseline within a certaintimeframe, but this timeframe can be different for different phases andviscosities.

The integration of arrays of thermal sensors into ostomy bags and/orwafers can aid patients as well as their care givers, nurses andspecialist doctors to manage peristomal skin complications and to takeearly action to prevent the skin condition of the ostomy patient fromworsening. Further, patients and caregivers may be able to understandmore about the patient's output and the function of their GI system.Specific temperature sensor technologies, as well as other sensortechnologies, for wafers and bags are described in greater detail belowwith respect to the drawings.

The smart ostomy bag can also detect the volume/fill inside the bag,such as by using the same thermistor technology mentioned above. Thethermistor technology described above can detect the volume from thethermal signature of the effluent output; such as by placing thethermistor sheet in front of or in back of the bag (e.g., in either afront wall or a back wall of the bag). The time frame of the thermalsignature of the volumetric output can indirectly indicate viscosity andeventually phase of the effluent (such as liquid, solid, semi-solid, andpotentially even gas).

The thermistor based sensor technology can have a two-fold functionalityin the smart bag: 1) indicating skin irritation and leakage in theperistomal region and 2) indicating volume fill in the bag as well asphase of the effluent released. Both data sets can be generated based onheat. Below is an explanation of the processes and principles used bythe device to generate output for each of these measures.

Because the transduction principle of the thermistor sheet can be basedon temperature change and not on bending as the flex sensor is in U.S.Pat. No. 9,642,737, the thermistor technology can be more immune fromnoise caused by movement and therefore a new candidate for volumetricindication in the bag. Additionally, in example implementations wherethis thermistor sheet is placed at the front of the bag, the sheet candetect the temperature distribution/diffusion of the content within thebag and also the flow pattern of the stoma output. This can furtherallow analyzing the rheology properties of the stoma output, andpotentially allows identifying the phase of the output.

The temperature readings themselves can be derived from resistancereadings of the thermistors at a particular temperature as a function oftime. The thermistor can be a semiconductor based device that changesits electrical resistance as a function of applied temperature. Theresistance value can then be converted to a temperature value via theSteinhart-Hart equation:

$\frac{1}{T} = {A + {B\;{\ln(R)}} + {C\left\lbrack {\ln(R)} \right\rbrack}^{3}}$where T is the temperature (in Kelvin), R is the resistance at T (inohms), and A, B, and C are the Steinhart-Hart coefficients which canvary depending on the type and model of thermistor and the temperaturerange of interest.

The sensors can send data to an electronic hub, which can packetize thedata and send the packets to a cloud server and/or to a mobileapplication on a user device. The mobile application can read thewireless packets and convert them to their appropriate data types. Themobile application can also be in electrical communication with thecloud server to download the data. The mobile application can output,for presentation to a user, a map of the heat distribution throughoutthe wafer and the front side of the bag, a temperature versus timescattered plot, and/or as visual representation of the total volume ofoutput in the bag.

Example Ostomy Monitoring System

In FIGS. 1B and 1C, a schematic overview of an ostomy monitoringenvironment 100 is provided in which an ostomy device 102—as well asoptionally a patient (not shown) using that device 102—may be monitored.In this environment 100, a hub 122 of the ostomy device 102 is shown incommunication with a user device 130 (see FIG. 1B), which can transmitdata from the hub to a backend system 170 (such as a remote server orcloud server) over a network 140, or directly with the backend system170 over the network 140 (see FIG. 1C). The user device 130, the backendsystem 170, and other devices can be in communication over the network140. In some cases, such as shown in FIGS. 1B and 1C, the user device130 can download processed data from the backend system 170 after thehub 122 transmits the data to the backend system 170 for furtherprocessing (although in FIG. 1C, the backend system 170 can communicatedirectly with the hub 122 instead of through the user device 130). Theseother devices can include, in the example shown, a clinician device(s)160, and third party systems 150. The ostomy monitoring environment 100depicts an example environment, and more or fewer devices maycommunicate with the ostomy device 102 in other systems or devices. Theostomy monitoring environment 100 can enable a user and others (such asclinicians) to monitor various aspects related to the user's ostomydevice 102, such as ostomy bag fill, leaks, and skin irritation.

The ostomy device 102 can be a one-piece or two-piece device includingan ostomy wafer 104 and an ostomy bag 120.

The ostomy wafer 104 can include a patient-facing side that has anadhesive pad, flange, or the like that attaches to a patient's skinaround a stoma 110 and a bag-facing side that is opposite thepatient-facing side. The stoma 110 can include any stoma disclosedherein, for example, an aperture or hole in a patient's abdomen (orother location) resulting from a colostomy, ileostomy, urostomy, orother similar medical procedure. The ostomy bag 120 can removably attachto the bag-facing side of the ostomy wafer 104 (such as via adhesives ora Tupperware click mechanism) and receive and store output (for example,effluent) from the stoma 110. The ostomy bag 120 can be flexible so thatwhen the bag 120 can be substantially flat when empty and can expand aseffluent enters the bag 120. Once the ostomy bag 120 has reached itsdesigned capacity, the patient (or caregiver) may remove the ostomy bag120 from the ostomy wafer 104, discard and/or empty it, and attach a newostomy bag 120 (or clean and reattach the old ostomy bag 120). Inanother example, the ostomy bag 120 is provided or sold together withthe ostomy wafer 104 as a single device, with the ostomy wafer 104integrally formed with the ostomy bag 120. The ostomy bag 120 collectshuman waste (such as stools and/or urine) from patients who cannotexcrete waste naturally due to medical issues, which span from cancer,trauma, inflammatory bowel disease, bowel obstruction, infection, andincontinence. In such cases, a procedure is performed where a wastepassage is created (colostomy, ileostomy, or urostomy) and diverted to asection of the abdominal wall. The ostomy bag 120 can be made ofnon-porous sterile plastic materials such as, but not limited to,polyvinyl chloride, polyethylene, ethylene vinyl acetate, polypropylene,and copolyester ether.

The ostomy bag 120 can include one or more sensors 124 and a hub 120,which can be located on a side facing away from the wafer 104. Thesensors 124 can include any of the sensors described herein. Forinstance, the sensors 124 can include a plurality of temperaturesensors, capacitive sensors, a camera (infrared or visible light), a gassensor, a magnetic sensor such as an AMR sensor, and/or microfluidicsensor(s), among others. The bag 120 can include multiple layers. One ormore sensor layers may be provided in which sensors are embedded orotherwise attached. Different types of sensors may be on differentlayers, or different types of sensors may be on a single layer. Thesensors can also be located on the same and/or different sides of asingle layer.

The ostomy bag 120 can include a measurement sheet. The side of theostomy bag 120 facing away from the wafer 104 can include themeasurement sheet. The measurement sheet can include a plurality oflayers (such as layers made of polyimide, polyurethane, or the like). Aswill be described in greater detail below, four or two layers can beused. Other numbers of layers can be used. A layer of temperaturesensors and/or a layer of capacitive sensors, for instance, may beprovided that detects temperature and/or capacitance changes as effluententers the bag 120 and disperses about an interior of the bag 120. Thetemperature and/or capacitive sensors may each be arranged in a matrixor matrix-like arrangement. A processor, whether in the hub 122(discussed below), the user device 130, or the backend system 170, canprocess the temperature and/or capacitance data obtained from thetemperature and/or capacitive sensors to detect leakage and/or skinirritation metrics, such as an increase in temperature and/or bag fill.Electronics in communication with the sensors can also be provided onone or more of the layers. Other examples of the sensors with respect tothe bag are discussed in greater detail below.

The ostomy wafer 104 can be a flexible sheet with one or more layers,and optionally, multiple layers including one or more sensor layers. Thelayers can be made of the same or similar materials as the layers of thebag 120 described above. One or more of the layers of the ostomy wafer104 may include one or more of the following sensors: temperaturesensors (such as thermistors, temperature sense integrated circuits(ICs), thermocouples, infrared (IR) temperature sensors, etc.),capacitive sensors, flex sensors, odor sensors, microfluidic sensors,leak sensors, combinations of the same, or the like.

The sensors (such as temperature sensors and/or other types of sensorsdisclosed herein) of the ostomy wafer 104 can be disposed in a sensorlayer (described in detail below). The sensor layer can have a similaror the same shape outline as the ostomy wafer 104. For example, if theostomy wafer 104 is shaped like a donut or annulus, the sensor layer mayinclude a generally annular shape. The sensor layer can also have ashape that differs from the general shape of the wafer 10, such as apartially annular or partial ring shape. Optionally, the ostomy bag 122can include a carbon filter port to allow gas to escape. An optional gassensor placed on or near the port can detect a characteristic about thegas, such as the pungency of the gas to determine the status of theuser's gut.

The ostomy wafer 104 can be any size. The size of the ostomy wafer 104can depend on the type of stoma that the wafer 104 is used with. Forexample, a colostomy stoma can be larger than a urostomy stoma. Thus,the ostomy wafer 104 can be sized larger for some colostomy stomas thanfor some urostomy stomas. The ostomy wafer 104 may be a “one-size fitsall” wafer that has punch-out sections in the center for adapting tovarious different stoma sizes. The ostomy wafer 104 can also come indifferent versions, which have stoma holes 110 of different sizes toaccommodate different stoma sizes.

The ostomy wafer 104 can also be in any of a variety of differentshapes. For example, the ostomy wafer 104 can have a generally annular,ovular, or circular shape, such as a ring, donut, or the like. Theostomy wafer 104 can also have a more rectangular, oblong, or squareshape (optionally with rounded corners).

As described above, the ostomy wafer 104 can be layered in structure toencapsulate the sensors. Encapsulation can improve fixation of thetemperature sensors in position in the flexible sheet and/or reducecorrosion of the sensors by the external environment. As an alternativeto encapsulation, the temperature sensors may be protected fromcorrosion by a coating, such as a conformal coating. Some example wafers(and bags, discussed below) can have at least one temperature sensor ina second region of the flexible sheet that is protected by a conformalcoating.

As described above, the patient-facing side of the ostomy wafer 104 canhave an adhesive side that adheres to skin around a stoma 110 and/ordirectly to the stoma 110. The adhesive can be a double-sided adhesive.The adhesive may be a hydrocolloid adhesive.

The sensors of the ostomy wafer 104 and/or the bag 120 can detectinformation based on the output of the stoma 110. The sensors can sensethe constituents of the effluent or output of the stoma 110. Temperaturesensors can be used to determine whether there is likelihood ofinflammation at the site of the stoma and/or a leak. Temperature sensorsmay also be used to detect the phasing of the constituents, which can beused to determine, for example, how much gas and/or solid is in the bag.A capacitive sensor in the wafer 104 (and/or in the bag 120) may serveas a fallback, provide redundancy to, and/or supplement a temperaturesensor to determine if there is a leak. For example, the temperaturesensors on the wafer 104 can detect a leak due to the effluent notentering the bag for various reasons as described above in addition tooverfill of the bag 120 (such as when the bag 120 is relatively emptybut the adhesives on the wafer become loose). As another example, thetemperature and/or capacitive sensors on the bag 120 can detect bag filland output an indication of an imminent overfill or leak, before anactual occurrence of a leak. In another example, capacitive sensors canbe used instead of temperature sensors to detect leaks or skinirritation.

If microfluidic sensors are used on the wafer 104 and/or the bag 120,the sensors can be used to detect electrolyte or inflammation markerswithin the constituents. This data can be used to show the user what heor she could intake or do to obtain a healthier balance of electrolytesand other chemical compositions in the user's body. An odor sensor canbe incorporated into the bag 120 and/or the wafer 104 to determinewhether there is bacterial growth in the digestive tracts. An inertialmeasurement unit (“IMU”) sensor, a form of positional indicator, canalso be integrated into the bag 120 and/or the wafer 104. An opticalsensor, such as a camera, may also be integrated into the bag 120 and/orthe wafer 104 where the sensor looks down over the stoma and/or into bagin order to detect a degrading stoma, blood in stool, or etc. An audiosensor, such as a microphone, can be included in the bag and/or thewafer to detect gas output and/or bowel movement sounds. pH sensors mayalso be integrated into the bag 120 and/or the wafer 104 to determinethe acidity of the constituents of the bag.

The ostomy wafer 104 and the ostomy bag sensor(s) 124 can collectpatient data related to the stomal output and can transmit the datawirelessly or with wires to the hub 122. The hub 122 can includeelectronics that can facilitate one or both of (1) processing sensordata and (2) transmitting sensor data. For instance, the hub 122 caninclude a hardware processor, memory, and a wireless transmitter. Thehub 122 can also optionally have a display for outputting data relatedto the sensors (such as an indication of a leak, bag fill, or the like).The hub 122 can also optionally include a speaker that outputs anaudible warning indicative of a leak, bag fill, or the like.

The optional wireless transmitter of the hub 122 can send data receivedfrom sensors (wafer or bag) to a user device 130. The data can then besent to a network 140, third-party systems 150, a clinician device 160,a backend system 170, or to a patient data storage device 180 (each ofwhich is discussed in greater detail below). In order to preservebattery life, the wireless transmitter may be switchable to an activemode and idle mode. The wireless transmitter of the hub 122 can alsosend data received from the sensors on the wafer 104 and/or the bag 120to the backend system 170, such as shown in FIG. 1C. The wafer 104and/or the bag 120 can send data periodically, for example, overBluetooth. The data transmitted by the hub 122 can include unprocessed,or conditioned (such as filtered, demodulated, and so on) signal data.The backend system 170 can process the received signal data to calculatethe metrics disclosed herein, such as temperature and/or capacitancevalues, bag fill volumes, and/or leakage detection. The user device 130and/or other devices can download the calculated metrics from thebackend system 170. Performing the calculation on the backend system 170can reduce the need for processing power in the hub 122, which can inturn reduce battery consumption and/or frequency in changing orrecharging a battery in the hub 122.

The optional wireless transmitter of the hub 122 may include anear-field communication (NFC) reader and/or writer, a Bluetoothtransmitter, a radio transmitter, or a Wi-Fi (802.11x) transmitter. TheNFC reader and/or writer can be coupled to NFC antennas on the hub forcommunicating with NFC antennas on the bag 120 and/or the wafer 104 toreceive sensor data from the sensors on the bag 120 and/or the wafer104. The NFC reader and/or writer can have sufficient power or current(for example, with an output current up to about 250 mA) to receive datatransmitted by the NFC antennas on the wafer 104 (and/or the antennas onthe bag) when the bag 120 is filled to its apparent capacity and/or whenthe wafer 104 is separated from the hub 122 by a certain (for example,maximum) distance. The NFC reader and/or writer can serve as the mainwireless communication tool with the sensors on the bag 120 and/or thewafer 104, and Bluetooth communication can optionally serve as a backuptool. Different wireless communication protocols can also optionally beused for transmitting data among the hub, the ostomy bag, and/or thewafer. The Bluetooth transmitter may include a Bluetooth module and/or aBluetooth low energy (BLE) module. A Bluetooth module may be, but is notlimited to, a Bluetooth version 2.0+EDR (Enhanced Data Rates) module. ABluetooth low energy module may be a Bluetooth module such as, but notlimited to, a Bluetooth version 4.0 (Bluetooth smart), a Bluetoothversion 4.1, a Bluetooth version 4.2 or a Bluetooth version 5. TheBluetooth sensor module may include a Bluetooth module using IPv6Internet Protocol Support Profile (IPSP).

The hub 122 can be in various positions on the device 102. The hub 122can be placed in many areas on the ostomy bag 120. The hub 122 can beplaced in the front, the back, next to a gas filter (not shown), or thelike. The hub 122 can also be placed in a pocket on the ostomy bag 120or the hub 122 could be a replaceable feature on the ostomy bag 120. Thehub 122 can also come in different forms. When the hub is removed froman ostomy bag 120 it can use previous collected data and carry over thatdata to the next subsequent ostomy bag 120 that it is placed upon. Hubremovability can save money for the user.

The hub 122 can include a plurality of electronics, including but notlimited to the wireless transmitters and/or receivers, motion sensor(such as a three-axis accelerometer), temperature sensors (such as farinfrared (FIR) temperature sensors, ambient temperature sensor, and/orthe like), camera module, lighting for the camera (such as LEDlighting), a microphone (such as a microelectromechanical (MEMS)microphone), battery charging circuitry, and/or other electronics. Theambient temperature sensor, which can be any type of temperature sensor,can be mounted on a side of the hub 122 facing away from the bag and thepatient. Temperature measurements from the ambient temperature sensorcan approximate a room or ambient temperature, and/or serve as referencefor the temperature sensors on the bag 120 and/or the wafer 104. Themicrophone can record audio information related to the stomal outputand/or monitor the metrics related to the stomal output (for example,gas output, bowel movement, or others).

The user device 130 can be any device with a processor and a wirelessreceiver that can communicate with the hub 122. For example, the userdevice 130 can be a phone, smart phone, tablet, laptop, desktop, audioassistant or smart speaker (such as an AMAZON ECHO™, GOOGLE HOME™, APPLEHOMEPOD™, or the like), television, or the like, that may pairautomatically to the wireless transmitter and may include a mechanismthat advises the user of the existence of a wireless link between thewireless receiver and the wireless transmitter. The user device 130 mayhave software and algorithms to process the data to show the user thestatus of the fill of the bag, the nearest restroom, nearest sources ofelectrolytes, nearest source of food, patterns and contents ofdischarge, hydration levels, and recommendations to improve the user'scondition. The user device 130 may also transmit the data wirelessly toa network 140. The network 140 can be a local area network (LAN), a widearea network (WAN), the Internet, an Intranet, combinations of the same,or the like.

The third-party systems 150 can be a data processing tool/feature;backend servers for audio assistants; or fitness trackers, personalhealth monitors, or any third party systems that can use or manipulatethe data collected by the device 102. These third-party systems 150 mayalso include algorithms and software to calculate and process the data.

Third party systems 150 and audio assistants can fetch data from theostomy device 102 to announce reminders or alerts for the user such asto empty the bag, change the bag, change the hub, intake or stopintaking certain types of food, intake water, and/or providing periodiccheck-ins. Other third party systems may use data collected from otherusers to create a better feedback system or to identify patterns withina demographic of ostomy patients and/or bag users.

The clinician device 160 can be a data processing tool or monitoringprogram used by a clinician. These clinician devices 160 may receivedata from the device 102 to provide a remote clinician to diagnosis theuser, recommend actions to the user, or function as an augmented realitysystem for the clinician. These clinician devices 160 may also includealgorithms and software to calculate and process the data.

The backend system 170 (such as cloud servers) can also use algorithmsand software to perform data processing. For instance, the backendsystem 170 can process any data received from the sensors on the waferand/or bag and return information based on that processing to the userdevice 130 or other devices. Another optional feature is an inclusion ofa patient data storage system 180. From here the backing system can sendthe data to the patient data storage wirelessly or the patient datastorage can access the data from the network 140.

Algorithms and software can show when the user should replace the bag,alert the user when the bag is nearly full or when there is a leak inthe wafer or bag. Software features include, but are not limited to,identifying the nearest restrooms within the user's radius, the volumeof the user's bag, alarms for different fill levels, a hydration andelectrolyte tracker which calculates the user's recommended dailyhydration goal with an algorithm. The hydration and electrolyte softwarecan notify the user based on their effluent output or constituents whathis or her dietary needs may be throughout the day.

Example Ostomy Wafers and Ostomy Wafer Layers

An ostomy wafer (also called an ostomy flange or an ostomy barrier) isan example of an article designed to adhere to the peristomal skin of astoma patient. The wafer can protect the skin from chemical andbiological erosion caused by stomal output.

FIG. 2 shows an example sensor layer 200 of an ostomy wafer, such as thewafer 104 of FIGS. 1B-C, which contains sensors 202 such as temperaturesensors (for example, thermistors) or any of the other sensors discussedherein. The sensor layer 200 includes a body 212 surrounding a hole 210(which may be a punch-out or cut-out to fit a user's stoma) and a neck214. The example sensor layer 200 can be made out of a flexible sheetmaterial.

The sensors 202 shown are placed in the body 212 in a roughly circularpath around the hole 210. Any number of sensors 202 may be included.Having sensors 202 disposed in a roughly circular distributionconcentric with the hole 210 can facilitate detecting leaks orirritation in different directions or any direction. More sensors may beprovided in some implementations to increase a granularity ofmeasurement, to potentially more accurately predict which direction aleak or irritation occurs, for example.

Also depicted is a sensor 204 disposed on the neck 214 extending awayfrom the hole 210. The neck 214 may be resiliently deformable, such thatit is able to lengthen in response to movement of the stoma patient andsubsequently return to its original form. The sensor 204 can act as areference sensor for comparing a temperature difference between thesensors 202 and the sensor 204. Because the sensor 204 is farther fromthe hole 210 than the other sensors 202 in this example, temperaturedetected by the sensor 204 may represent a baseline temperature of thepatient's skin. Thus, comparison of the temperature output from thesensors 202 with the temperature output of the sensor 204 can beindicative of a leak or irritation. More generally, in order to detectthe presence or absence of inflammation in the peristomal skin, at leastone temperature sensor in the sensor layer 200 may be positioned remotefrom the hole 210 (once formed). This could be, for example, in theperipheral region of the body 212 or in the neck 214. The use of asensor in the peripheral region of the body 212 to measure a user'sreference body temperature signature in certain instances may be cheaperthan manufacturing a sensor 204 in the neck 214.

Although the body 212 of the sensor layer 200 is shown as having acircular or annular shape, the sensor layer 200 may have other shapes.For example, the sensor layer 200 may be oblong, square, or ovular.Additional example shapes for the sensor layer are described in greaterdetail below.

Also, the sensor layer 200 may be one of multiple layers of materialthat form the ostomy wafer 104. For instance, the sensor layer 200 maybe sandwiched between two or more layers to form the ostomy wafer 104.For example, the ostomy wafer 104 may include at least one layer formedof a protective plastics such as, but are not limited to, polyethylene,polypropylene, polystyrene, polyvinyl chloride, polyurethane,acrylonitrile butadiene styrene, phenolic, polyetheretherketone,polyamides, or combinations thereof. In certain examples of the device,the ostomy wafer 104 includes at least two layers of a protectiveplastics material, dimensioned to fully encapsulate at least theplurality of temperature sensors in the first body 212 and/or the neck214. Encapsulation ensures or attempts to ensure that the temperaturesensors are held in position in the sensor layer 200 and that they areprotected from corrosion by the external environment.

Encapsulation may be achieved, for example, by sandwiching thetemperature sensors between two layers of a protective plasticsmaterial, and subsequently heat welding or adhering the two protectivelayers together to form the ostomy wafer 104. In order to encapsulatethe temperature sensors and still conform to the shape of the body, theostomy wafer 104 can be from 0.15 mm to 0.7 mm thick or some otherrange. As an alternative to encapsulation, the temperature sensors maybe protected from corrosion by a coating, such as a conformal coating.In certain systems, at least one temperature sensor in the secondregion, for example, in the neck 214 can be protected by a conformalcoating.

In order to detect inflammation through temperature changes on theostomy, temperature sensors placed in the positions of sensors 202 canbe used. Temperature sensors may be thermistors, resistance temperaturedetectors (RTDs), thermocouples, integrated circuit sensors or infraredtemperature sensors. The temperature sensors can be thermistors.Thermistors may be particularly suitable temperature sensors due totheir high sensitivity. The thermistors may be commercially availablethermistors that provide a large temperature coefficient of resistance,for example, in the range of about 30° C. to about 50° C. or some otherrange. Such thermistors are widely commercially available, for example,thermistors from Panasonic, the NTC thermistors NCP15WF104D03RC orNCP15XH103D03RC from Murata Manufacturing Co., Ltd or the NTC thermistorNTCG103JX103DT1 from TDK Corporation. When the temperature sensors arethermistors, the system (e.g., the hub 122) may include a processor thatcan periodically poll the electrical resistance of each thermistor.

FIG. 3 shows an example sensor layer 300. Like the sensor layer 200, thesensor layer 300 may be part of an ostomy wafer, such as the wafer 104.Accordingly, the sensor layer 300 may be sandwiched between two or morelayers to form an ostomy wafer.

The sensor layer 200 may be a “pre-cut,” a “cut-to-fit,” or a “moldable”wafer. When the wafer is a “pre-cut” wafer, the size of the opening 210may be in the range of from about 20 mm to about 100 mm in diameter.Other sizes are possible. When the wafer is a “cut-to-fit” wafer, theostomy wafer may include a pattern of indicia defining at least oneseverance region. This arrangement can allow the user to size theopening to their stoma, by selecting the appropriate part of the ostomywafer to remove. The sensor layer 200 may include severance regionswhich can include a plurality of concentric circles or partial circles(or concentric ovals or partial ovals), such that severing the sensorlayer 200 at each of the concentric circle or partial circle (orconcentric ovals or partial ovals) can provide an opening of a differentsize. For example, the severance region may include a pattern of three,four, five, or more concentric circles or partial circles.

The sensor layer 300 includes a plurality of thermistors indicated byletters and numbers on the figure. In particular, these thermistors arenumbered A1 through D10. The thermistors are arranged annularly about ahole 210 (or cutout 210 that may be removed to form a hole). Inparticular, the thermistors are arranged in concentric rings 304, 306,308. These rings are connected by wiring, shown in blue and red. Thus,although the thermistors are arranged approximately circularly aroundthe hole 210, the connections formed by the conductors connected to thethermistors form approximate partial circles or partial rings around thehole 210. An area 310 of conductors represents an example bottom of theneck 214 of FIG. 2 and is shown truncated for illustration purposes.

In this example, the sensor layer 300 has a plurality of temperaturesensors in three rings 304, 306, 308, measuring the temperature in aninner region of the sensor layer 300 (for example, the ring 304 or inthe neck 310); at least one temperature sensor in an outer region of thesensor layer 300 for measuring the temperature in the outer region ofthe sensor layer 300 (for example, the ring 308), the outer region beingremote from the inner region. Although not shown, a comparator orprocessor may be provided (e.g., in the hub 122 and/or the backendsystem 170) that can compare the temperature in the first region of thesensor layer 300 with the temperature in the second region of the sensorlayer 300, and thereby produce a difference signal indicative of thepresence or absence of skin inflammation in a region of skin in contactwith the first region of the sensor layer 300.

In some systems, the system can be arranged to facilitate skininflammation detection around a wound. For example, the temperaturesensors may be positioned in the sensor layer 300 such that when thewafer 104 including the sensor layer 300 is applied around a stoma onthe skin surface, the plurality of temperature sensors in the firstregion of the sensor layer 300 can detect the temperature of skinadjacent to the wound and at least one temperature sensor in the secondregion of the sensor layer 300 can detect the temperature of skin remotefrom the wound. This arrangement can allow a temperature differencebetween skin adjacent the wound and skin remote from the wound to beattributed to inflammation. By providing a system with the ability tocompare the temperature in a first region of the sensor layer 300 withthe temperature in a second, remote, region of the sensor layer 300, andtransmit to a receiver a signal corresponding to the detectedtemperature difference, the system can detect the presence or absence ofskin inflammation in a region of skin in contact with the first regionof the sensor layer 300 and report on its detection to a user.

FIG. 4 shows example components of the sensor layer 200 in an exampleostomy wafer 400. The ostomy wafer 400 may have all the functionality ofthe ostomy wafer 140 and other example ostomy wafers discussed herein.Although incorporating the sensor layer 200 for illustration purposes,the sensor layer 300 may be used in an example implementation.

The example ostomy wafer 400 also has an adhesive layer 406 at least onthe peristomal skin contact side 408 of the ostomy wafer 400 foradhering to skin. A bag interface layer 402 of the ostomy wafer 400 canalso have an adhesive (on opposite side from figure; not shown) that canattach on an ostomy bag such as the ostomy bag 120.

Encapsulation sheets 404 can be protective plastics such as, but are notlimited to, polyethylene, polypropylene, polystyrene, polyvinylchloride, polyurethane, acrylonitrile butadiene styrene, phenolic,polyetheretherketone, polyamides, or combinations thereof. Beforeencapsulation, the sensors 202 may be mounted on, or integrated into, asupport sheet 401. The support sheet 401 may be formed of a plasticsmaterial, such as polyethylene terephthalate (PET), polyurethane (PU),or combinations thereof, or of a polyimide film, such as Kapton (thecondensation product of pyromellitic dianhydride and 4,4′-oxydianiline).The use of a support sheet 401 can ensure or attempt to ensure that thetemperature sensors are held in position during the encapsulationprocess. This enables the temperature sensors to be strategicallypositioned on the wafer. The example severance circles 408 depicted withinner circle 410, middle circle 412, and outer circle 414, can functionas a guide for a user to customize the size of the ostomy hole 210 bycutting along the severance circle traces. In some variation, the wafermay not include the encapsulation sheets, but can include other types ofprotective material to protect the electronics of the wafer.

The adhesive 406 may be a hydrocolloid adhesive. Hydrocolloid can be abiocompatible material consisting of pectin, carboxymethylcellulose(CMC), gelatin, polymers and other adhesives, for example. The use of ahydrocolloid adhesive may be suitable in ostomy applications because itcan adhere to the skin surrounding the stoma, whether it is a moist or adry skin site. In the case of wound exudates, which are very common inostomy applications, the polymer in the hydrocolloid dressing can absorbthe fluid and swell, protecting the wound, causing less pain and fasterhealing. In the case of ostomy applications, where bags are changed onlyafter 2 or 3 days, the hydrocolloid dressing may be beneficial, as ithas a long wear life once worn, causing reduced disruption to the wound.Furthermore it may be impermeable or less permeable to bacteria thanother materials.

FIG. 5 shows another example of a sensor layer 500 that may be includedin the ostomy wafer 104 or in any other ostomy wafer discussed herein.The sensor layer 500 is similar in some respects but different in otherrespects from the sensor layer 200 and the sensor layer 300. In general,the sensor layer 500 can include many of the features of either thesensor layer 200 or the sensor layer 300. For example, the sensor layer500 includes sensors 502, which may be thermistors or other sensors asdiscussed herein. The sensors 502 are disposed in a body 512 of thesensor layer 500. The body 512 connects to a neck 514. The sensor layer500 may also be disposed between two or more other layers to form anostomy wafer, as discussed above with respect to FIGS. 2 through 4.

The sensor layer 500 differs from previously described sensor layers inthat sensor layer 500 includes a gap 501 between portions of the sensorlayer 500. This gap 501 creates a structure that looks approximatelylike a menorah. The sensor layer 500 can include a plurality of partialrings formed by cutout regions or sections. The sensor layer 500 caninclude a first cutout section 504, a second cutout section 506, a thirdcutout section 508, and a fourth cutout section 508. These cutoutsections, similar to the severance regions 408 of the ostomy wafersdescribed above, can aid in customization of a stoma size hole 210. Auser can use the cutouts as guides to resize the stoma hole 210.

The neck 514 has a serpentine design with zigzags 507 to aid inflexibility. The neck 514 can include conductors much like the neck 214described above.

FIG. 6 shows an example implementation of the sensor layer 500, thesensor layer 600. Sensor layer 600 includes all functionality of thesensor layer 500 and also depicts wiring between thermistors 502. Thewiring includes curved wiring between the thermistors, which takes theshape of half circles, some of which alternate direction.

FIG. 7 shows an example circuit schematic 700 that represents schematicarrangement of the sensors 202 (as well as 302 or 502). In the exampleschematic 700 shown, a matrix of 4×4 sensors 202 is shown. Any of thesensor layers described herein can connect the sensors together in amatrix such as shown in FIG. 7. Although the matrix in FIG. 7 isdepicted as rectangular, this is an option but is also merely schematicand can be varied in layout. For example, the layouts of the sensors inthe previous figures differs from the rectangular layout as shown, butthe sensors in those figures may have the same interconnections in amatrix topology as shown in FIG. 7.

FIGS. 32-35C illustrate an example sensor layer 3200 of an ostomy wafer,such as the wafer 104 described above. The sensor layer 3200 can haveany of features of the sensor layers 200, 300 described above. Thesensor layer 3200 can be incorporated into the wafer 104, 400 describedherein. For example, the wafer including the sensor layer 3200 caninclude an adhesive layer on a patient contact side, an adhesive layeron an ostomy bag contact side, and/or one or more encapsulation sheetsmade of polyimide film (such as KAPTON™), polyurethane, or the like.

As shown in the schematic drawings in FIGS. 32-33B, the sensor layer3200 can include a body 3212 and a neck 3214. The body 3212 can begenerally circular or ovular. The neck 3214 can be generally rectangularand can extend from the body 3212. The relative position of the neck tothe body is not limiting. The body 3212 can include a stoma hole 3210configured for fitting over a user's stoma. The hole 3212 can have avariable diameter (for example, about 38 mm, or about 45 mm, or others)according to the size of the stoma. The body of the adhesive layer, andoptionally the sensor layer and/or encapsulation layer described herein,can also have different sizes and/or shape to, for example, accommodatedifferent stoma sizes, offer different amount of surface area forattachment to the skin, or otherwise. In some configurations, the waferexamples described herein can have an increased border size and/orborder tape to reduce peeling off of the wafer from the user's skin. Thewafer may include a border ring surrounding the adhesive layer. In someimplementations, the border ring can have a greater outer dimension thanthat of the adhesive layer. The border ring of the wafer can includeacrylic adhesives and/or the hydrocolloid adhesives. The hydrocolloidadhesive at the border may have a different thickness than thehydrocolloid adhesive of the remainder of the wafer. The border ring canalso be referred to as a tapered edge.

The body 3212 can accommodate a plurality of temperature sensors 3202(such as thermistors disclosed herein). As shown in FIG. 32, the body3212 can include forty temperature sensors 3202. The temperature sensors3202 can be distributed generally over the body 3212. The temperaturesensors 3202 can be arranged in a generally circular pattern that issubstantially concentric with the hole 3210. As shown in FIG. 32, thetemperature sensors 3202 can be arranged in an inner ring 304 and anouter ring 306. Different numbers and/or different arrangements oftemperature sensors can also optionally be used. The surface on whichthe temperature sensors 3202 are mounted can be facing the patient.

The body 3212 can also optionally accommodate one or more capacitivesensors. Any other wafer examples described herein can include one ormore capacitive sensors. For example, one or more capacitive sensors canmonitor a moisture content of the hydrocolloid in the adhesives, whichcan provide an indication that the adhesives have dried up and/or thewafer needs to be replaced.

As shown in the schematic drawings in FIGS. 33A-B, which illustrate asurface of the layer 3200 opposite the surface on which the temperaturesensors 3202 are mounted, the neck 3214 can accommodate electroniccomponents 3222 and/or power source 3224 on that surface. The electroniccomponents 3222 can be mounted (for example, surface mounted) on aprinted circuit board (PCB) 3223, such as shown in FIG. 33B. The PCB3223 can be mounted on the layer 3200. The PCB 3223 can be sufficientlyrigid to protect the electronic components 3222 and/or the circuitry onthe PCB 3223 from breaking due to the bending of the flexible layer3200. The electronic components can be mounted directly on the layer3200 (for example, without a PCB), with stiffening material(s) (forexample, fiber glass, plastic, or others that are more rigid than thematerial of the layer 3200) mounted on the layer 3200 adjacent to theelectronic components to protect the electronic components frombreaking. Mounting the electronic components 3222 on the PCB 3223 canreduce the number of encapsulation layers (for example, from four layersfor directly mounted electronics to two layers for PCB-mountedelectronics) in the sensor layer of the wafer, which can reduce the useand/or waste of the encapsulation materials, and/or make the wafer moreaffordable to users.

The electronic components 3222 can be electrically coupled to thetemperature sensors 3202 (as will be described in greater detail below).The electronic components 3222 can receive data from the temperaturesensors 3202. When the temperature sensors 3202 include thermistors, theresistance of the thermistors can vary with respect to temperaturechanges (such as when there is a leak of the effluent from the stoma).The electronic components 3222 can receive resistance signals from thetemperature sensors 3202 and/or condition the resistance signals. Theelectronic components 3222 can send ADC values and/or other minimallyprocessed signals to the hub, such as the hub 122 described above, forcalculating the temperature values on a cloud and/or a user's device toreduce power consumption by the wafer electronic components 3222. Thewafer electronic components 3222, the user device, and/or the hub canalso optionally perform the calculation of the temperature values.

As shown in FIG. 33B, the power source 3224 can include a battery (suchas a coin cell battery). More than one battery can also optionally bemounted to the neck 3214. The battery can be surface-mounted to the neck3214 adjacent to the electronic components 3222. As shown in FIG. 33B,one or more mounting arms 3225 can be attached to the neck 3214 forholding the battery in place.

FIGS. 34A-C illustrate top, perspective, and side views of the examplesensor layer 3200. As shown, the sensor layer 3200 can also include aplurality of NFC antenna rings 3208. The NFC antenna rings 3208 can belocated radially outwardly from the outer ring 3206 of the temperaturesensors 3202. The NFC antenna rings 3208 can be generally concentricwith the inner and/or outer rings 3204, 3206 of the temperature sensors3202. The NFC antenna rings 3208 can be manufactured onto the layer 3200(for example, printed or etched). When in use, the ostomy bag, such asthe ostomy bag 120 described above, can be coupled to (for example,adhesively attached to) the wafer such that the NFC antenna rings 3208on the sensor layer 3200 substantially coincide with NFC antenna ringson the sensor layer of the bag (described in greater detail below)and/or the NFC antenna rings on the hub. The NFC antenna rings on thewafer, the bag, and the hub can have substantially the same dimensionsto facilitate better data transmission between the wafer and the hub andbetween the bag and the hub. The NFC antennas on the wafer, the bag,and/or the hub can also optionally have other shapes and/or sizes, suchas ovular, square, rectangular, or polyhedral shapes.

As also illustrated in FIGS. 34A-B, conductive traces 3230 (such ascopper traces) can connect the temperature sensors 3202, the NFC antennarings 3208, and/or the power source 3222 to the electronic components onthe PCB 3223. The sensor layer can also include more rings, such as moreNFC antenna rings and/or conductive traces rings as illustrated. FIGS.35A-C illustrate example schematic circuit diagrams of the sensor layer3200. FIG. 35A illustrates an example schematic circuit diagram 3510 ofthe wafer PCB 3223. The actual arrangement of the electronic componentscan be varied in the wafer PCB layout. FIG. 35B illustrates an exampleschematic circuit diagram 3520 of the temperature sensors 3202. Asdescribed above, the actual arrangement of the temperature sensors canbe varied on the wafer. However, those temperature sensors can have thesame interconnections in a matrix topology as shown in FIG. 35B byconductive traces 3230 or wires. FIG. 35C illustrates an exampleschematic circuit diagram 3530 of the battery.

As also illustrated in FIGS. 34A-B, the traces 3230 connected to thetemperature sensors 3202 and the traces 3230 connected to the NFCantenna rings 3208 can cross at various locations. When the hub needs tocommunicate with the electronic components 3222, the hub communicatesusing the NFC antennas on the hub with the NFC antenna rings 3208 toestablish connection between the hub and the electronics 3208. The hubcan turn on its NFC, which powers the antenna to allow the hub tocommunicate with the ostomy bag and wafer. The electronics 3208 can readdata from the temperature sensors 3202 (such as the ADC values or othervalues described above). The hub can then turn off the temperaturesensor circuit on the wafer before the electronics 3208 transmit thetemperature sensor data to the hub via NFC communication. The hub canalso turn on the temperature sensor circuit when the wafer stopstransmitting data to the hub. Deactivating the temperature sensorcircuit during data transmission between the wafer and the hub canreduce interference due to the crossing of the traces.

As described above, the sensor layer 3200 (or other sensor layersdisclosed herein) can include one or more polyimide films. The sensorlayers disclosed herein can also be made of polyurethane. The use ofpolyurethane can allow silver traces to be used instead of the coppertraces. Silver traces can have improved biocompatibility, lowertoxicity, and/or better antimicrobial properties than copper traces.Thus, silver traces can reduce irritation for some patients sensitive orallergic to some metals.

Example Ostomy Bags and Bag Layers

FIG. 8 shows example sensors that can be layered upon or in the ostomybag 120 of FIG. 1B. This can provide multiple different readings byusing a limited amount of space on the device 102. The layered sensor800 can have, but is not limited to, a flex sensor 802, an odor sensor804, a microfluidic sensor 806, a capacitive sensor 808, a memory foamlayer 810, and a thermoreceptor layer 812. The layered sensors 800 canalso have a hub 814, which can be an electronics hub and is an exampleof the hub 122.

The hub 814 can have any of features of the hub 122 of FIGS. 1B-1C. Forexample, the hub may contain, among other components, a hardwareprocessor such as a microcontroller/SoC, as well as a wireless circuitor module. The hub 814 can send the data collected by the layeredsensors 800 to another device, cloud, server, or any other kind of datastorage or data processing system (see, e.g., FIG. 1B).

An optional flex sensor 802 can be used to help determine whether thebag is nearing a full level. An odor sensor 804 can determine whetherthere is bacterial growth in the gut as reflected in the effluent.

A microfluidic sensor 806 can be used to detect electrolyteconcentration, inflammation biomarkers, pH values, and likewise of thefluid. The microfluidic sensor 806 can include a sensor with slotsconfigured to receive the fluid in the output. The microfluidic sensorcan be small in size compared to the size of the ostomy bag. This datacan be used to show the user what he or she may need to intake to obtaina healthy balance of electrolytes. The data can be obtained fromelectrical sensors and/or optical sensors with chemical assays. Theelectrical sensors can detect different amount of electricity generateddepending on the concentration of the electrolyte of interest. Theoptical sensor, such as a camera or a photodiode, can detect colorchanges in the chemical assays.

The example capacitive sensor 808 may have an onboardmicrocontroller/SoC (system on a chip), or a capacitive sensor chip thatmay read in the value received from the capacitive sensor then translateit to “output present/not present.” Multiple capacitive sensors could bepolled. This data can be processed on the microcontroller/SoC andconverted to volume then sent to the application running on the phone orthe unprocessed data can be sent directly to the application on thephone for processing. This data can also be transmitted, via the hub, tothe backend system for calculating the volume values.

The capacitive sensor(s) 808 may also serve as a fallback to and/or beused in combination with one or more temperature sensors to determine ifthere is a leak. For example, two capacitive sensor layers can be usedwith a cloth-like material in between. When the stoma interface issaturated from leaks, the cloth like material may be wet and provide aconduit for the capacitive sensors to activate and alert the user of aleak.

The example thermistors in the thermoreceptor layer 812 can be used todetermine leaks and irritation. Leaks may have a sudden direct pathpattern heat map signature. Irritation may have a gradual radiating heatmap signature. The thermoreceptor layer 812 could also detect phasing ofthe material collected in the bag. When a substance phases betweenliquid, gas, and solid, the speed of temperature change can correlate.Gas often gives false volume readings so that detection of gas may behelpful in filtering false volume readings. In currently availableostomy products, there is no good way to tell how much gas in the outputand therefore there are many false readings and leads to wasting notfully utilized bags. Temperature monitoring may allow a device and userto distinguish between volume fill from liquid or gas. This detectioncan allow the device estimate how much gas is in the bag with thetemperature sensor 812. A bag fill algorithm can subtract the estimatedgas volume from the fill of the bag.

The thermoreceptor layer 812 can have an onboard microcontroller/SoC(System on a chip) that may poll each thermistor in the arrayindividually by using multiplexer/de-multiplexer. (Of course, this chipmay instead be in the electronics hub 814.) The signal from themultiplexer/de-multiplexer may then be fed into a series of operationalamplifiers which may yield a voltage. That voltage may be read by themicrocontroller/SoC using an Analog to Digital converter. From thisvoltage, the device can calculate the resistance from the thermistorthat was polled. From that resistance, the device can calculate thetemperature at that specific thermistor. This is repeated for allthermistors. Data from some or all of these sensors can be sent to theapplication on the user device at any stage. For example, to offloadprocessing from the hub to the backend system and/or to the phone, athermistor's resistance value or just the ADC values may be sent. Theuser device may then take that resistance value and calculatetemperature. The application on the user device may know which datacorrelates to which thermistor by the location of the data in the packetbeing transmitted.

Further sensors, such as any of the sensors disclosed herein, can beintegrated into the bag. For example, an inertial measurement unit(“IMU”) sensor, a form of positional indicator, can be integrated. Thedata received from the IMU sensor may be read into themicrocontroller/SoC using data lines such as I2C, or SPI. The data isthen processed and sent off the application or alternatively can beprocessed and used internally for the volume calculation. Accelerometersmay also be integrated. Accelerometers may be able to tell if thepatient is engaged in physical activity, such as running (and henceshould have an expected higher skin temperature), and can also helpdistinguish between whether a user is supine, sitting, or standing. Thiscollected data can then alter the algorithm to determine the referencetemperature of the user and compare the temperature data collected bythe temperature sensors.

An optical sensor may also be integrated where the sensor looks downover the stoma and into the bag in order to detect a degrading stoma,blood in stool, etc. The optical sensor may use infrared light or acamera. This optical sensor may give augmented reality features or 3Dmapping features to a clinician. The patient can be prompted to take aphoto of the stoma, for example, after being discharged from thehospital, between time intervals (such as every morning), or wheneverthe patient puts on a new bag. The patient can be prompted to upload theimage to a central server (such as a cloud server) via the applicationon the user device described herein. The application can process theimage to cross-check with the output volume estimated using any of thealgorithms described herein to improve accuracy of the outputestimation. A user could also use the optical sensor or a camera intheir user device to point to the bag or stoma to allow a clinician tohelp diagnose the issue. This feature could be used in conjunction withoperating a remote diagnosis center where clinicians can aid patients indetermining how to treat their issues via augmented reality. The stomaimage can allow a physician to check the condition of the stoma, such asfor signs of infection, presence of blood in the output, and otherwise.The stoma image can be added to a database of stoma images, which helpclinicians in building a knowledgebase and/or analytical informationabout stoma (such as infection or inflammation). Machine learningalgorithms or other types of mathematical models can be used to buildthe knowledgebase. The clinician's input regarding the stoma images canalso be fed into the algorithm to further improve accuracy of theknowledgebase.

An audio sensor, such as a microphone can also be integrated. The audiosensor can be used to monitor stoma gas output, and/or bowel sounds. Forexample, lack of bowel sound can indicate constipation or bowelobstruction. Bowel sounds can also indicate when the user is hungry andshould be fed. The bowel sounds collected by the microphone can be alsoused to build a knowledgebase of how certain bowel sounds may correlateto and predict certain bowel movements. The audio sensor output can beused to correlate the user's feeding and stoma output timing. Theoptical and audio sensors can be used in combination to detect stomasite observations, such as blood, new wounds, or otherwise. In someimplementations, an alarm can be triggered at pre-set protocols uponcertain stoma site observations. In some implementations, the audio(such as a microphone) and/or optical (such as a camera) sensors can beselectively turned on and/or off. For example, the optical sensor may bedeactivated until the audio sensor detects gas output. Selectiveactivation of the optical sensor and/or audio sensor can save batteryusage and increase battery life of the hub.

As described above, microfluidic sensors cannot only include electrolytedetection, but also may detect inflammatory markers such as C-reactiveprotein detection, fecal calprotectin, and other inflammatory markers.Moreover, pH sensors may also be integrated into the microfluidic sensoras well to determine the acidity of the constituents of the bag 902.Microfluidic sensors may also detect other biological markers, such asdehydration markers, inflammation markers, certain drugs, and others.Using the microfluidic sensors described herein can advantageously allowthe electrolytes and other parameters of the stoma output be measured atthe stoma site instead of being carried out in a separate procedure inlaboratory setting using a patient's urine sample.

FIG. 9 shows an example bag with a single sensor layer 900. The bag 902has sensors 202 arranged in an array 904. The sensors 202 can be any ofthe sensors discussed herein, including temperature sensors or any ofthe sensors described above with respect to FIG. 8.

FIG. 10 shows a front view of an example sensor layer 1000. The side ofthe example sensor layer 1000 facing away from the user shows an examplehub 1002 placed upon a sensor layer 200. The hub receives data from thesensor layers.

FIG. 11 shows an example user facing side of an example sensor layer1100. The example sensor layer 1100 can have multiple sensors 202 placedupon a sensor layer 200. FIG. 12 shows example wiring of a layer 1200that can be placed on a bag 902. The wires may be curved or havehalf-circle shapes between different sensors to provide for flexibilityunder patient movement.

FIG. 13 shows an example bag 902 with a sensor layer 800 that can beconnected to a partial ring ostomy wafer 500 layer. The partial ringwafer layer 500 can be connected to the sensor layer 800 at the hub 814.The example sensor layer 500 of an ostomy wafer is also shown. Bothsensor layers 500, 800 are connected to an example electronics hub 814.Not shown, but which may be included, are other layers to cover thesensor layers 500, 800 as discussed above.

FIG. 14A shows an example layered ostomy wafer 400 from FIG. 4 placed onan example ostomy bag 902. The example layered ostomy wafer 400 canperform all the functionality of the ostomy wafers discussed above.

FIG. 14B shows an example ostomy bag 902 with layers of sensors 1400that faces away from the user. The ostomy bag 902 is another example ofthe bag 120 of FIG. 1B. Generally speaking, the bag can include twowalls, a patient-facing wall and an away-from patient facing wall. Thewalls may be stitched, pressed, glued, welded, or otherwise connectedtogether at a seam. The bottom of the bag may be sealed or may have aselectively openable portion for draining. Either or both of the wallsmay include one or more layers.

In this example, a layer of sensors 1400 is connected to an example hub1410, which in this example is crescent-shaped for improved weightdistribution (for example, to avoid the weight of the hub flopping thebag over, which may be irritating to users). The hub can have agenerally circular cross-section, such as shown in FIGS. 44A-44B, whichillustrate example front and back views of a generally circular hub4400. The hub can have a generally circular cross-section with a flatside, such as shown in FIGS. 46A-46E. A connection port 4602 can beaccessed on the flat side. As shown in FIG. 46E, the hub 4600 caninclude a hub roof 4604 and a hub base 4606 enclosing electroniccomponents 4608 between the roof 4604 and base 4606. The hub can alsoinclude a lens cover 4610 configured to be disposed around a cameraopening 4612 to protect the lens of a camera installed in the hub 4600.

An outer dimension of the hub can accommodate the NFC antenna rings inthe hub, which can be of substantially the same size as the NFC antennarings on the ostomy bag. The layer of sensors 1400 can collect data offthe material (effluent) that is collected in the bag 902. In thisexample, Layer 1 1401 is the outermost layer that contains no sensors.In this example, Layer 2 1402 is free of sensors but in other examples,this layer could be populated with sensors. In this example, Layer 31403 is populated with a capacitive sensor array to detect volumetricfill (this is not fixed and the sensor could change or its position inthe bag could change). In this example, Layer 4 1404 is free of sensorsbut in other examples, this layer could be populated with sensors. Inthis example, Layer 5 1405 is the closest layer to the bag. In thisexample, Layer 5 has a thermistor sheet to detect volumetric fill, andsensors to detect the phase and the viscosity of the output. Layer 3 andLayer 5 can be switched in position. The capacitive sensor array and thethermistor sensor array can also be located on the same layer. Thislayer of the bag may also use an analytical microfluidic sensor (as itis the closest to the output) and the thermistor sheet may then beplaced in another position in the bag. The stomal output in this examplecan reside between Layer 3 and Layer 4.

In this example, the necks 1406 of the layers of the sensor sheets canbe coated with conformal coating, such as protective plastics such as,but are not limited to, polyethylene, polypropylene, polystyrene,polyvinyl chloride, polyurethane, acrylonitrile butadiene styrene,phenolic, polyetheretherketone, polyamides, or combinations thereof.

In this example, a gas sensor 1408 may also be placed over the carbonfilter gas valve 1504. The carbon filter gas valve can allow gas toescape the bag 902 while being treated for the odor. The gas sensor 1408can be used to detect the constituency of the gas. Too pungent a gas canbe an indicator of bacterial overgrowth. A strong pungency can correlateto overly-high effluent output, which may be dangerous for a user. Themore pungent the odor, the more issues the user's gut may have that maywarrant possible medical attention.

The crescent hub 1410 is used on the top of the bag in this example. Hubplacement may influence weight distribution of the bag. In someexamples, a round hub concentrates weight in a single area with theweight of the gas sensor 1408 and may be too heavy for the device andlead to bag movement. If the weight is spread in a crescent shape, theweight can be distributed more evenly on the top of the bag and therebyreducing bag movement.

FIG. 14C illustrates another example ostomy bag 1430 having a pluralityof layers including an insulation layer 1432 located between an outercover layer 1434 and the ostomy bag layer 1436. The ostomy bag layer1436 can be made of any of the materials disclosed herein, such asnon-porous sterile plastic materials including but not limited to,polyvinyl chloride, polyethylene, ethylene vinyl acetate, polypropylene,and copolyester ether. A sensor layer 1438 can be located on one side ofthe ostomy bag 1436, such as a side away from the user. In this manner,the sensor sheet can be placed in front of the layer behind which theoutput occurs, so the output can be monitored while it comes out. Thisarrangement of layers may of course be varied. The sensor layer 1438 canhave any of the sensor arrays disclosed herein. In some configurations,the sensors and electronics can be printed on the ostomy bag layer sothat the bag may not include a separate sensor layer. The insulationlayer 1432 on the patient-facing side of the bag can protect the sensorlayer from the heat from the patient body. The insulation layer 1432 onthe side of the bag that faces away from the patient can also protectthe sensor layer from noise from the ambient environment. The insulationlayer can be made of any nonconductive material with highly insulatingproperties, such as PET felt (polyester), polyurethane or polyesterfoams, any thermally insulating fabrics or textiles, STYROFOAM™, oraerogels. The insulation layer can also include memory foam material soas to better conform the bag to the contour of the patient's body.

As shown in FIGS. 14C-14D, the outer cover layer 1434 on the side of thebag facing away from the patient can include a pocket 1440 configuredfor accommodating an electronic hub. The hub can be removed from the bag1430 that is about to be discarded and be used on a subsequent new bag.The hub can use data on previously collected a preceding ostomy bag toimprove algorithm processing for subsequent bags.

FIGS. 15A-15G depict an example ostomy wafer 400 attached to exampleostomy bags 902 with additional different example electronics hub 814placements. As disclosed above, different hub placements may affect theweight distribution of the bag, which can affect bag movement. Differenthub placements can also affect the wearability of the device. Thefigures depict a patient surface view 1500 that has the example ostomywafer 400 and a front surface 1502 with a sensor layer 800. There isalso a carbon filter 1504 in this example. The carbon filter can helpgas escape the bag and eliminate the odor. Additionally, some exampleshave a gas sensor 1408 which may be used to determine the bacterialactivity of the user's gut. Some examples include hook and loop patches1503 in the shapes of circles or rectangles with neck flaps 1505 toenable the bottom portion of the bag to be selectively opened fordraining and closed for receiving effluent.

FIG. 15A shows an example device that has a hub 814 in the middle of thebag. FIG. 15B shows an example device with a hub 814 with two USB ports1506, 1508. The USB ports can be MicroUSB or USB-C ports, among othervariations. The USB port feature may create some rigidity in the centerof the bag. The hub 814 may also plug in and pull out like a USB device.This modularity can allow a hub 814 to be reused in a different bag.This modularity can also allow an alternate way for the sensors to be incommunication with the hub. The connection between the sensor and thehub could be via USB. In this scenario, some or all the circuitry fromthe different sensors could be affixed to a single port and the USBinlet could affix into a USB inlet in the hub. Other connection methodscan include the hub connecting to the bag sensors or wafer sensors usingmezzanine-style connectors and/or FPC/FFC connectors, among many otherpossible variations.

Additional devices may also be plugged in to the USB connectors to givethe device additional functionality. For example, a visualization devicesuch as a display, a speaker, a battery, a USB memory stick to obtainhub data, an external data source, or a hard drive with updated orcustomized algorithms may be inserted to these USB ports 1506, 1508. OneUSB port instead of two may be provided, or more than two may beprovided.

FIG. 15C shows an example hub 814 placed over the charcoal filter 1504on the top of the bag 902. FIG. 15D shows a hub 814 placed next to acarbon filter 1504 near the top of the bag. FIG. 15E shows a hub 814placement behind the hydrocolloid layer of the example ostomy wafer 400but on top of the bag 902. FIG. 15F shows a hub 814 in a pocket 1510.This design is another example of a reusable hub. The hub can be removedfrom a bag 902 that is about to be disposed and then be used on asubsequent new bag 902. The hub can use previously collected data on apreceding ostomy bag 902 to improve algorithm processing for subsequentbags.

FIG. 15G shows an example approximately crescent-shaped hub 1410 placedat the top of the ostomy bag 902. For the examples that show a hubplacement at the top of the bag, a visualization element such as anoptical sensor, camera, or IR camera may be connected to the hub via aUSB port and descend into the bag to give visualization input of thecontents of the bag 902. These example additional parts and devicecomponents mentioned in FIGS. 14A-15G can be seamlessly integrated sothat there may be little difference in user experience in using andinstalling these components. The parts may be standardized for easy useruse and can be designed to be used in a modular function where a usercan pick and choose which sensors are more pertinent to their condition.

In some examples, the device 102 may be manufactured in differentconfigurations. In one configuration, several sensors may be used in abag and/or wafer. The device may be targeted for new stoma patients andnew users where a large collection data may be beneficial for the user.An ostomy bag according to the present disclosure can include any (suchas all) of the sensors, biomarkers (for example, for cancer cells,blood, and the like), and/or electronics. Such a bag can be a diagnosticbag configured to be worn by a patient after surgery and before beingdischarged. It can be more critical to monitor a variety of parametersof the patient immediately after a surgery. However, a diagnostic bagcan be expensive. Other configurations may provide a user to choosewhich sensors pertain to their condition and provide a cheaperalternative. Other configurations may have the bare minimum of sensorsfor advanced patients who may be acclimated to their stoma condition,such as only temperature sensors in the wafer and/or bag. A simpler andless expensive ostomy bag, such as an analytics bag with fewer sensors,biomarkers and/or electronics than the diagnostic bag, can also be usedto monitor phases of the stoma output, skin temperature changes (andthereby skin infections), and/or stoma/output images/sounds via a cameraand/or microphone in the electronic hub in addition to detecting outputvolume and leak. The analytics bag can be used a predetermined period oftime after the surgery, such as two weeks, one month, three months, sixmonths, twelve months, or any ranges between those values, or afterbeing discharged from the hospital. The patient can also optionallyswitch to another ostomy bag, a maintenance bag, that includes justsensors and electronics for volume and leak detection. The maintenancebag can also optionally include sensors and electronics for trackinghydration or dehydration of the patient. The patient can switch to themaintenance bag a predetermined time after the surgery, such as sixmonths, nine months, twelve months, eighteen months, twenty-four months,or any range between those values. In some implementations, a medicalkit can include one or more of the diagnostic bags, one or more of theanalytics bags, and one or more of the maintenance bags.

FIGS. 36-42D illustrate an example sensor layer 3600 of an ostomy bag,such as the bag 120 described above. The sensor layer 3600 can have anyof features of the sensor layers 800, 1100 described above. The sensorlayer 3200 can be incorporated into the bag 120, 902 described herein.For example, an ostomy bag incorporating the sensor layer 3200 caninclude a plurality of sensors, a hub interface, an ostomy waferinterface, and/or encapsulation sheets made of polyimide film,polyurethane, or the like.

As shown in the schematic drawings in FIGS. 36-40B, the bag sensor layer3600 can have an outline shaped and sized generally like the ostomy bag.The sensor layer 3600 can have a first portion 3612 and a second portion3614. When in use, the first portion can substantially coincide with thestoma hole of the wafer, such as described with reference to FIGS.32-34B, and/or with the effluent entrance of the bag. When in use, thesecond portion 3614 can substantially coincide with a remainder of thebag configured to hold the effluent.

When in use, the bag can be attached to the hub generally within thefirst portion 3612. As shown in FIGS. 36-40B, the first portion 3612 caninclude an opening 3632 (such as an oblong opening extending along alongitudinal axis of the sensor layer 3600). The opening 3632 can allowlight to travel unobscured between a camera on the hub from one side ofthe layer 3600 to an opposite side of the layer 3600, or allow thecamera on the hub to protrude at least partially through the opening3632. The opening 3632 can allow monitoring of the stoma via the cameraon the hub. The camera can be configured to capture a central portion ofthe stoma due to the proximity of the camera lens and the stoma. Camerawith wider angle or smaller focal lens can also be used to captureimages showing a larger area of the stoma.

As shown in FIG. 36, the second portion 3614 and at least a part of thefirst portion 3612 immediately adjacent to the second portion 3614 canaccommodate a plurality of temperature sensors 3602 (such as thermistorsdisclosed herein). The sensor layer 3600 can include sixty-fourtemperature sensors 3602. The temperature sensors 3602 can be arrangedin an 8×8 matrix, which can improve an even distribution of thetemperature sensors across the part of the sensor layer 3600 that maymore likely come into close proximity with the effluent during normaluse of the ostomy bag to detect temperature changes due to changes inthe bag fill level. Different numbers and/or different arrangements oftemperature sensors can also optionally be used. In some configurations,fewer temperature sensors (such as about 20) can be used. Thetemperature sensors can measure a plurality of metrics related to thestomal output as disclosed herein.

As shown in FIG. 37, the second portion 3614 and at least a part of thefirst portion 3612 immediately adjacent to the second portion 3614 canaccommodate a plurality of capacitive sensors 3604. The sensor layer3600 can include twelve capacitive sensors 3604. The capacitive sensors3604 can each include an electrode (such as silver or gold electrodes)coupled to a capacitive sensor chip, which will be described in greaterdetail below. The capacitive sensors 3604 can measure a capacitancechange when effluent enters the bag as the solid and/or liquid contentsof the effluent have different capacitance values than a capacitancevalue of the bag or air in the bag.

As shown in FIG. 37, the capacitive sensors 3604 can be distributed overthe sensor layer 3600 such that at least some of the capacitive sensors3604 can detect a bag fill level when the bag is in an upright positionand/or a tilted position of various angles. For example, as shown inFIG. 37, the capacitive sensors 3604 can be distributed symmetricallyabout a central longitudinal axis of the sensor layer 3600. Thecapacitive sensors 3604 can be located in different vertical and/orhorizontal positions on the sensor layer 3600. As shown by the dash-dotlines in FIG. 37, some of the capacitive sensors 3604 can be generallyaligned in straight lines inclined at various angles to detect bag filllevels when the bag is tilted to different angles (see FIG. 39B). Theseangles can be, for example, from about 30° to about 70°, or from about40° to about 60°, or from about 50° to about 55°, or about 52.57°, orabout 52.79°, or about 53.02°, or about 53°. The angles are not limitedto the values shown in FIG. 39B. In addition, more capacitive sensors3604 are located in the second portion 3614 (such as eight, ten, orothers) than in the first portion 3612 (such as four, two, or others),which can permit more lines of different angles to be formed by thecapacitive sensors 3604 in regions of the bag that are more likely tocontain the effluent.

The arrangement of the capacitive sensors 3604 can permit more accuratedetection of the bag fill level, such as when compared to arranging thesame number of capacitive sensors in a traditional matrix-likerow-column arrangement. For example, the matrix-like row-columnarrangement of the same number of capacitive sensors can result in apattern of lines of the sensors with fewer angle variations, which canlead to less accurate detection of the bag fill when the bag is tilted.In the matrix-like row-column arrangement, there is also a more evendistribution of the capacitive sensors in the first and second portions3612, 3614 of the sensor layer, resulting in fewer sensors in the secondportion 3614, where the bag is more likely to contain the effluent. Forcapacitive sensors in a traditional matrix-like row-column arrangementto detect the bag fill level at different positions of the bag to thesame or substantially similar degree of accuracy as the capacitivesensor arrangements disclosed herein, a greater number of capacitivesensors would be required. Therefore, the capacitive sensor arrangementsdisclosed herein can permit more accurate detection of the bag filllevel with few numbers of capacitor sensors.

The capacitive sensors 3604 can also be located such that a “bag full”(or close to full) indication can be outputted, such as by the userdevice, before the bag has reached its designed capacity (for example,about 5 mL, about 10 mL, or any other volumes before the bag reaches itsdesigned capacity). The user can be alerted, for example, by the userdevice, when the capacitive sensors 3604 that are closer to the opening3632 (such as CS1, CS0, CS2, CS3) detect a capacitance change that isindicative of the effluent. Detection of the effluent around thosecapacitive sensors 3604 can indicate the bag is close to reaching itsdesigned capacity. Alerting the user prior to the bag reaching itsdesigned capacity can provide time for the user to get ready fordraining and/or changing the bag, thereby reducing the risk of a leak.Different numbers (such as sixteen, or other numbers) and/or differentarrangements of capacitive sensors (including the electrodes and/or thecapacitive sensor chips) can also optionally be used. In someconfiguration, more capacitive sensors (such as about 36 to 48) can beused.

As shown in FIG. 38, the sensor layer 3600 (for example, on a top layer)can include both the plurality of temperature sensors 3602 describedwith reference to FIG. 36 and the plurality of capacitive sensors 3604described with reference to FIG. 37. As shown in FIG. 39A, the sensorlayer 3600 as shown in FIG. 38 can also further include a plurality ofopenings 3634 in the layer. The openings 3634 can vary in size,location, and/or number. The plurality of openings 3634 can improve theflexibility of the sensor layer 3600.

As shown in the schematic drawings in FIGS. 40A-B, which illustrate asurface of the layer 3600 opposite the surface on which the temperaturesensors 3602 and/or the capacitor sensors 3604 are mounted, the sensorlayer 3600 can accommodate electronic components 3622 and/or powersource 3624 on that surface. The electronic components 3622 and/or powersource 3624 can be located approximately in the center of the layer3600.

The electronic components 3622 can be mounted (for example, surfacemounted) on a printed circuit board (PCB) 3623, such as shown in FIG.40B. The PCB 3623 can be mounted on the layer 3600. The PCB 3623 can besufficiently rigid to protect the electronic components 3622 and thecircuitry on the PCB 3623 from breaking due to the bending of theflexible layer 3600. The electronic components can also optionally bemounted directly on the layer 3600, with stiffener material(s) (forexample, fiberglass, plastic, or others that are more rigid than thematerial of the layer 3600) mounted on the layer 3600 adjacent to theelectronic components to protect the electronic components frombreaking. Mounting the electronic components 3622 on the PCB 3623 canreduce the number of encapsulation layers (for example, from four layersfor directly mounted electronics to two layers for PCB-mountedelectronics) in the bag sensor layer, which can reduce the use and/orwaste of the encapsulation material, and/or make the ostomy bag moreaffordable to users. The PCB can also optionally include two rigidportions placed adjacent each other. The PCB can be foldable along theadjoining sides of the two portions to improve flexibility of the bag.In some implementations, the electrical circuits, such as including thetemperature sensors and any other sensors, can be printed on the ostomybag layer instead of having a separate sensor layer. Reducing the needfor a separate sensor layer can further improve flexibility of the bagand allow the bag to conform better to the user's skin.

The electronic components 3622 can be electrically coupled to thetemperature sensors 3602. The electronic components 3622 can alsoinclude a capacitive sensor chip 3621 electrically coupled to thecapacitive sensors 3604. The electronic components 3622 can receive datafrom the temperature sensors 3602 and/or the capacitive sensors 3604.For example, the electronic components 3222 can receive resistancesignals of the temperature sensors 3602 and/or the capacitive sensors3604, and/or condition the resistance signals from the temperaturesensor 3602 and/or the capacitive sensors 3604. The electroniccomponents 3622 can also send ADC values and/or other conditionedsignals to the hub for calculating the temperature and/or capacitancevalues on a cloud and/or a user's device to reduce power consumption bythe bag electronic components 3622. The bag electronic components 3622,the hub, and/or the user device can also optionally perform thecalculation of the temperature and/or capacitance values.

As shown in FIG. 40B, the power source 3624 can include a battery (suchas a coin-cell battery). More than one battery can also optionally bemounted to the sensor layer 3600. The battery can be surface-mounted tothe sensor layer 3600 adjacent to the electronic components 3622. Asshown in FIG. 40B, one or more mounting arms 3625 can be attached to thesensor layer 3600 for holding the battery in place.

FIGS. 41A-B illustrate top, perspective, and side views of the examplesensor layer 3600. As shown, the sensor layer 3600 can also include aplurality of NFC antenna rings 3608. The NFC antenna rings 3608 canextend around the camera opening 3632. A portion of the NFC antennarings 3608 can also be located near the electronic components 3622 andthe power source 3624. The NFC antenna rings 3608 can be generallyconcentric to one another. Similar to the NFC antennas 3208 on the wafersensor layer 3200, the NFC antenna rings 3608 can be manufactured ontothe sensor layer 3600 (for example, printed or etched). When in use,such as shown in FIG. 45, an ostomy bag 4500, which incorporates thesensor layer 3600, can be coupled to (for example, adhesively, or viahook and loop Velcro dots, attached to) the hub 4400 such that the NFCantenna rings 3608 on the sensor layer 3600 substantially coincide withthe NFC antenna rings on the hub.

As also illustrated in FIGS. 41A-B, conductive traces 3630 (such ascopper traces, for example, copper plated with ENIG (Electroless nickelimmersion gold), or Immersion gold or silver traces as well as Hard Goldor any other PCB surface finish, depending on the material of the layer3600 as described above) can connect the temperature sensors 3602, thecapacitive sensors 3604, the NFC antenna rings 3608, and/or the powersource 3622 to the electronic components 3622 on the PCB 3623. FIGS.42A-D illustrate example schematic circuit diagrams of the bag sensorlayer 3600. FIG. 42A illustrates an example schematic circuit diagram4210 of the bag PCB 3623. The actual arrangement of the electroniccomponents can be varied in the bag PCB layout. FIG. 42B illustrates anexample schematic circuit diagram 4220 of the temperature sensors 3602on the bag sensor layer. As described above, the actual arrangement ofthe temperature sensors can be varied. However, those temperaturesensors can have the same interconnections in a matrix topology as shownin FIG. 42B by the conductive traces 3630 or wires. FIG. 42C illustratean example schematic circuit diagram 4230 of the capacitive sensors 3604on the bag sensor layer. As described above, the actual arrangement ofthe capacitive sensors can be varied. However, those capacitive sensorscan have the same interconnections as shown in FIG. 42C by conductivetraces 3630 or wires. FIG. 42D illustrates an example schematic circuitdiagram 4240 of the battery.

As also illustrated in FIGS. 41A-B, the sensor layer 3600 can furtherinclude a ground plane mesh 3628 extending circumferentially around theplurality of capacitive sensors 3604 and between the capacitive sensors3604. The ground plane mesh 3628 can reduce noise on the readings fromthe capacitive sensors 3604.

Another difficulty in accurately detecting electronically the level ofthe fill of an ostomy bag is the residue problem. When the stoma outputis more viscous, such as when the output includes feces or other moresolids, the more viscous components can cling to the inner surface(s) ofthe bag. The solids drying out (“pancaking”) on the inner surface of thebag can result in misleading or false level reading and thus volumecalculation. The dried solids can cause opposing inner surfaces of thebag to be stuck, obstructing entry and/or downward movement of theoutput discharged or infused into the bag. Prolonged exposure of thestoma to the “pancaked” output can also cause infection.

As will be explained below, recalibration of the capacitive sensors toupdate the baseline values of those sensors can help reduce theinfluence of the residue problem in the level and volume determination.Alternatively and/or additionally, more capacitive sensors (such asgreater than 12 capacitive sensors, for example, from about 36 to about48 capacitive sensors) can be used on the sensor layer of the ostomy bagto alleviate the effect of residue problem on the level readings. Morecapacitive sensors and/or increased capacitive sensor density canprovide greater resolution in the sensor reading, which can help detecta residue or “pancaked” output as the residue can have a more randomshape than the content of the output that has fallen to the bottom ofthe bag. Accordingly, more capacitive sensors and/or increasedcapacitive sensor density can improve the accuracy in predicting thevolume of the output. In some configurations, the sensor layer includingmore than 12 capacitive sensors may also include fewer than 64temperature sensors (such as about 20 temperature sensors).

Alternatively and/or additionally, the inner surface of the ostomy baglayer can be coated with a material, which can reduce the frictioncoefficient of the inner surface of the ostomy bag and guide the stomaoutput toward the bottom of the bag. For example, the material can behydrophilic or hydrophobic. Coating of the material can be achievedthrough a variety of ways, such as spraying, dipping, or otherwise. Thecoating can be effective throughout a life cycle of the bag and can bemore convenient than having to wash the inner surface of the bag withlubricating materials each time after the bag is drained. The coatingcan also be more convenient than applying an adhesive layer ofhydrophilic lubricating material to the inner surface of the bag,wherein the hydrophilic layer requires substantial moisture to becomehydrated and lubricious, so the beneficial effects of reducing theresidue problem the may not be realized unless the output dischargedinto the bag is sufficiently liquid to activate the hydrophilic coatingmaterial.

Example Algorithms

FIG. 16 shows a heat map 1600 generated by an algorithm that representsthe heat signature of the thermistor layer 812 of an ostomy wafer 400.The heat map may be output for display to a user, e.g., on the userdevice. The heat map can be used by the device 102 to determine whetherthe heat is an indication of a leak or inflammation. A user can use theheat map image to see how the effluent of a stoma is entering the bag.Data extraction by the user from the interface or, more succinctly, theexperience of interpreting data may be visual. Depending on the sensortype, the visuals may be different. A current example that can beprovided is temperature data from the thermistor layer. Here, the outputmay be in the form of a visual heat map. Each coordinate in the heat map(in the software interface) can be positioned such that it representseach thermistor in the approximately same position in the sheet. Hencethe temperature sensed by the thermistor can be seen visually in themap.

The data from the software on the hub, user device, or in the cloud(e.g., at the backend server) can also be extracted into a spreadsheetformat which allows more detail data analysis through the formulation ofgraphs through either Excel and other graphical software such as Origin.In bouts of inflammation, the center near the stoma 1601 may be at ahigher temperature than most of the outer edges and areas of the ostomywafer 400. A higher temperature in the center of the ring may representan area near the stoma that is potentially undergoing inflammation or aleak. In some examples, a reference sensor can be placed on the neck orthe reference sensors could be the outer edges of the device. Using theouter edge sensors that are already part of the device as a referencesensor may be a way to save costs instead of implanting a separatesensor on the neck

The visuals in the software can include: the temperature range value,indication of the quantitative value of the temperature in eachcoordinate, the log interval: 1) whether it should be on or off or 2)how frequently the data is collected and recorded. The software may alsohave the ability to drag across the elapsed time to be able to see thethermistor sheet as a function of time.

FIG. 17 shows an example leak detection process 1700. The leak detectionprocess 1700 can be implemented by the hub, user device, or backendserver as discussed above. More generally, the process 1700 can beimplemented by a hardware processor in any of those or another device.

The leak detection process can begin at block 1702, where temperature issensed from one or more temperature sensors in an ostomy wafer. Thetemperature may be sensed by the hub, or temperature sensor outputsignals may be obtained from the hub and transmitted to the user deviceor backend server to obtain temperature from the temperature sensoroutput signals.

At block 1704, the processor determines whether there is detected arapid change in temperature, for example, a change in temperatureoccurring within a threshold time. If so, the processor outputs anindication of a possible leak at block 1706. A leak of effluent underthe ostomy wafer or into the ostomy wafer can cause a rapid rise oftemperature—even a near-instantaneous rise in temperature. Thus,detecting such rapid changes in temperature can enable rapid leakdetection, which can result in warning the patient on the user deviceaudibly and/or visually. The patient can then address the leak, forexample, by changing the ostomy wafer and/or bag. By doing so, thepatient can potentially avoid skin irritation and ameliorate apotentially embarrassing situation.

FIGS. 18A-B shows an example device 1800 worn by a patient and a heatmap 1810 showing a stoma discharge flow. The heat map corresponds to anostomy bag sensor layer, as shown any ostomy sensor bag layer disclosedherein. The discharge flow is represented by an influx of a highertemperature reading across the thermoreceptor map. As effluent flowsinto a bag, near the top of the bag, the discharge flow moves toward thebottom of the bag. This flow can be tracked by tracking the change intemperature over time in the various rows or columns of the sensormatrix to predict that effluent has entered the bag. As a result, volumeof effluent in the bag can be tracked. Further, faster flowing effluentcan correspond to liquid and/or gas, while slower flowing effluent cancorrespond to solid or semi-solid materials. Thus, using a hardwareprocessor to monitor the change in temperature of the sensors over timecan indicate the type of effluent emitting from the stoma. Further,since gas can change temperature so quickly, the gas can be detected andits volume excluded from the bag fill calculation.

FIGS. 19 and 20 show example infusions of test materials into the bagand allowing the algorithm to show a heat map. FIG. 19 shows an infusionof heated applesauce at different volumes in a standing position 1900.The volume increasing as a function of the heat dissipated. The thickerapple sauce leaves a greater thermal foot prints on the bag, as thesauce is more viscous. FIG. 20 shows an infusion of water in a standingposition 2000 at various volumes from 50 mL up to 350 mL at 50 mLincrements. Visual thermal data (alongside the algorithms) canpotentially give indication of the position of the patients. This isspecifically from the thermistor sheet which can be integrated into thefront of the bag to detect the volume inside the bag, as well as otherphysical parameters such as phase and viscosity. Changing the positionfrom standing to supine, in the case of an ostomy bag for example,results in the orientation of the thermal signature being changed(specifically by rotation). This is because the thermistor sheet is in afixed position and orientation on the bag and the software is also fixedwith respect to a specific orientation of the sheet. As such, the changein the orientation of the patient, by default changes the orientation ofthe sheets and therefore the thermal signature and hence from the datait is possible to tell a change in position of the patient.

Visual data combined with the power of artificial intelligence,algorithms and software can allow the interpretation of not only outputoccurrence but also the phase of the output. This is based on the factthat different output types are associated to different viscosities.Liquid, for example, has a low viscosity and can flow. Hence as theliquid crosses the path of thermistors (in the array) and falls into theostomy bag, its rate of lighting up the thermistors may be faster than asolid or a semi-solid. Solids in contrast may have higher viscositiesand may not flow as fast as liquids. This suggests that the rate atwhich the thermistors light up may be a way to tell the phase of theoutput. The heat dissipation may also vary with viscosity as may thecooling rate. AI and algorithms such as a neural network model or anyother machine learning algorithms, can be developed to be able todifferentiate between the different phases. The machine learningalgorithms can be trained to recognize a sharp border between thermalfoot prints due to the different phases on the heat map. The resolutionof the border recognition can be improved with increased number oftemperature sensors over the ostomy bag.

The volumetric build-up in the bag can also be seen as a function ofgreater and greater output with time. Further incremental addition ofvolume in the bag to the volume that is already present in the bag, canalso be differentiated between where the fresh “waste” can bedifferentiated from waste that was already present in the bag. The heatchanges in the thermistor sheet can be used to assess the heatdistribution as a function of time with leakage and the on-coming ofskin irritation expected to raise the observed temperature around thestoma and alter the heat distribution. Although contributing factorssuch as humidity and sweat can act to also alter the temperature,reference sensors as well as AI and algorithms may be used differentiatebetween temperature increases due to background noise (sweat, humidity)and hone in on the active noise (due to sporadic active leakageoccurrence and skin inflammation due to active skin irritation).

FIG. 21 shows an example bag fill detection process 2100. The process2100 can be implemented by the hub, user device, or backend server asdiscussed above. More generally, the process 2100 can be implemented bya hardware processor in any of those or another device.

At block 2102, the hardware processor senses temperature withtemperature sensors in an ostomy bag. At block 2104, a change intemperature as a flow is detected. For instance, referring to thepreceding figures, the processor can detect the flow of effluent bydetecting changing temperatures in different rows or columns of the bagover time. The process 2100 can output at block 2106 an indication ofpossible increase in bag fill, and/or a warning that the bag may befull.

FIG. 43 shows an example bag fill determination process 4300. Theprocess 4300 can be implemented by the hub, user device, or backendserver as discussed above. More generally, the process 4300 can beimplemented by a hardware processor in any of those or another device.

The process 4300 can begin at block 4302, where the processor receivesreadings from one or more capacitive sensors and/or one or moretemperature sensors described above, such as with respect to FIGS.37-42D. The readings can include resistance readings of the capacitiveand/or temperature sensor(s) from which the processor can calculate thecapacitance and/or temperature values, or calculated capacitance and/ortemperature values (for example, performed by the electronic componentson the ostomy bag).

At block 4304, the processor can measure an effluent volume based on thereadings from the capacitive sensor(s) and/or temperature sensor(s). Theprocessor can calculate the effluent volume based solely on changes inthe capacitance values, solely on the changes in the temperature values,and/or a combination of changes in the capacitance values and thetemperature values (for example, using statistical methods). At block4306, the processor can output a bag fill level.

At decision block 4308, the processor can also optionally determinewhether the bag is full or almost full (for example, at a volume closeto the designed capacity, effluent having been detected by thecapacitive and/or temperature sensors at certain locations, or othersthat are disclosed herein). If the bag is full or close to being full,the processor can optionally output a “bag full” indication in block4310. The outputted indication can be displayed on the user device. Ifthe bag is not full or close to being full, the processor can return toblock 4302 to repeat the bag fill determination process 4300.

The smart ostomy bag can also detect the volume/fill inside the bag,such as by using an array of capacitive sensors. At least some of thecapacitive sensors on the bag can be used to detect the level of thefill in the bag, which can be converted to the volume of the output. Asshown in FIG. 47A, an example ostomy bag may include twelve capacitivesensors, CS0 to CS11 (which may be arranged as shown in FIGS. 37-39B).The capacitive sensors within the dashed line 4702 can be used for leveldetection.

At least some of the capacitive sensors can also be used to detectdraining of the bag. As shown in FIG. 47A, the capacitive sensors withinthe dashed line 4704, which can be located toward a lower portion of thesensor layer of the ostomy bag, can be used for drain detection. Theprocessor can determine whether the bag is being drained using a firstdrain criteria Σ_(i=7,8)ΔCS₁>C₃, where CS_(i) are the capacitive sensorreadings and C₃ is a constant that can be determined empirically, suchas based on patient studies data analysis. In some implementations, C₃can be 3. The processor can stop detecting level when the bag is beingdrained. The processor can also automatically calibrate the capacitivesensors after drain is complete.

Readings from the temperature sensors can optionally be used incombination with readings from the capacitive sensors in calculating thevolume/fill inside the bag and/or draining of the bag. Capacitivesensors may be better at detecting level as capacitive sensors may bemore resistant to noise, such as due to the residue problem, thantemperature sensors. As shown in FIG. 47B, an example ostomy bag mayinclude sixty-four temperature sensors, RT1 to RT64 (which may bearranged as shown in FIGS. 36 and 38-39B). The temperature sensorswithin the dashed line 4702 can be used for level detection. Thetemperature sensors within the dashed line 4704, which can be locatedtoward a lower portion of the sensor layer of the ostomy bag, can beused for drain detection. The processor can determine whether the bag isbeing drained using a second drain criteria

${{\sum\limits_{i = 57}^{64}{\Delta\; T_{i}}} < C_{4}},$where T_(i) are the temperature sensor readings and C₄ is a constantthat can be determined empirically, such as based on patient studiesdata analysis. In some implementations, C₄ can be −15. The processor canuse the first and/or second drain criteria in determining whether thebag is being drained.

At least some of the temperature sensors can also be used to detectwhether the bag is being worn by the patient and/or whether there isinfusion into the bag. As shown in FIG. 47B, the temperature sensorswithin the dashed line 4706, which can be located toward an upperportion of the sensor layer of the ostomy bag, can be used for infusiondetection. The temperature sensors within the dashed line 4706 can belocated near or in front of the stoma. The processor can determinewhether the bag is on the patient's body using an on-body criteria

${{\sum\limits_{\underset{{n = 0},1,2,3}{i = {3 + {8n}}}}^{6 + {8n}}T_{i}} > C_{2}},$where T_(i) are the temperature sensor readings and C₂ is a constantthat can be determined empirically, such as based on patient studiesdata analysis. In some implementations, C₂ can be 525. The processor candetermine whether the bag is on the patient's body using an infusioncriteria

${{\sum\limits_{\underset{{n = 0},1,2,3}{i = {3 + {8n}}}}^{6 + {8n}}{\Delta\; T_{i}}} > C_{1}},$where T_(i) are the temperature sensor readings and C₁ is a constantthat can be determined empirically, such as based on patient studiesdata analysis. In some implementations, C₁ can be 3.5. Detecting onsetof infusion when the patient is wearing the bag can trigger thecapacitive sensors (and also optionally the temperature sensors) tobegin level detection. Performing level detection after infusion isdetected can reduce false readings as level readings caused by increasein the output content in the ostomy bag. For example, false readings canbe caused by a variety of reasons, such as due to residue on the ostomybag inner surface, temporary pressure change, or otherwise.

Machine learning can be used to train the computer to detect the levelof the fill in the bag and thereby to predict an actual output based ona set of data from the capacitive sensors. Examples of machine learningmodes can include neural network, regression analysis, and/or the like.FIG. 48 illustrates an example neural network model for calculating thevolume of the output in the bag. Although the illustrated example usesonly capacitive sensor readings, such as readings from eight capacitivesensors, which can be the eight capacitive sensors within the dashedline 4702 in FIG. 47A, readings from the temperature sensors, such asthose within the dashed line 4702 in FIG. 47B can also be used in thevolume calculation. Resilient backpropagation (RPROP) algorithm can beused for supervised training of feedforward artificial neural network(multilayer perceptron). The neural network model can employ multiplayerperceptron architecture. As shown in FIG. 48, Principal ComponentAnalysis (PCA) 4802 can be applied to the capacitive sensors data in theinput layer 4812 to derive linearly uncorrelated variables (principalcomponents) and decrease dimensionality from eight to four. A sigmoidfilter 4804 can be applied to the hidden layer of four neurons 4814obtained from the application of the PCA to decrease dimensionality fromfour to three. A linear filter 4806 can be applied to the hidden layerof three neurons 4816 to derive an output layer of one neuron 4818,which can be used to determine the value of the volume 4808.

As each capacitive sensor may be different, calibration of eachcapacitive sensor may be performed to get the baseline value of eachcapacitive sensor. Each capacitive sensor may have its own calibrationvalues. Calibration can be done after the first measurements are donewhen the patient puts on the bag for the first time. The timing ofcalibration can reduce the effect of moisture from the stoma, which cancause baseline drift of the capacitive sensor when the patient puts onthe bag for the first time. The on-bag detection described above canalso be used to inform the processor to take a first measurement andthen calibrate the capacitive sensors. The output residue on the ostomybag can also result in capacitive sensors baseline drifting. FIGS.49A-49B illustrate capacitive sensors readings 4900 after the firstmeasurement is taken and after the bag is drained. As shown, at leastfour readings of the capacitive sensors, which are bounded by dashedlines 4902, have shifted their baseline values between the firstmeasurement (when the bag is empty) and after the bag is drained (andtherefore also empty). Recalibration of each capacitive sensor can beperformed to reduce the baseline drifting. Recalibration can beperformed after each drain and/or before the first infusion. The draindetection algorithm described above can be used to determine whenrecalibration is needed.

FIG. 50 illustrates certain algorithm logics used in volume calculation.When raw measurements 5000 are obtained from the sensors, which can bethe capacitive sensors and/or temperature sensors described herein, theprocessor can perform the infusion detection and/or drain detectionanalysis 5002, such as using the criteria described above. The processorcan optionally create infusion and/or drain flags. The processor cancheck for need to calibrate or recalibrate the capacitive sensorsbaseline 5004 based on the previously created flags, such as on-bagdetection, drain detection, and/or infusion detection flags. Afterperforming any necessary calibration or recalibration, the processor canperform a raw volume calculation 5006. As described above, the rawvolume calculation can be performed using a variety of machine learningtools, such as the neural network model shown in FIG. 48. The processorcan perform spike smoothing based on the previously created flags, suchas infusion and/or drain detection flags 5008. Certain logics derivedfrom clinical observations can also be used for spike smoothing. Forexample, a spike in volume calculation at a rate exceeding any possibleinfusion rate is likely not caused by an increase in output volume. Insome implementations, the spikes can be caused by patient movements orsudden pressure change. The smoothing can be performed using a varietyof ways, such as by applying a low pass filter, a median filter, orotherwise. The processor can also perform moving averages smoothing 5010to improve accuracy of the volume calculation before outputting anobservation of the volume calculation 5012.

Example User Interfaces

FIG. 22 shows an example user interface for a “Status Screen” 2200 or“Alfred Alert.” The Status Screen 2200 can display the current volume ofthe user's bag. In this example, there is a volume tracking circle 2202,a calibration button 2204, a drain button 2206, and an update tracker2208. The volume tracking feature can be achieved through Apple's nativeiOS library CoreBluetooth or another personal device's equivalent nativelibrary. CoreBluetooth is the library responsible for the communicationbetween the iOS device and the sensor device. The app can receiveBluetooth packets ranging from 7 to 11 bytes. The application canperform volume bag fill tracking using the process 2100 of FIG. 21.Alternatively, the application can perform the bag fill trackingalgorithm based on data received from a resistance sensor, rather thanor in addition to a temperature sensor array. The application can alsoperform bag fill and/or volume calculation based on a plurality ofcapacitive sensors and/or a plurality of temperature sensors asdescribed above with reference to FIGS. 47A-50.

In the temperature and capacitance examples, the application can convertreadings from the temperature and/or capacitive sensors to volume usingthe algorithms disclosed herein. As described above, the controller ofthe ostomy device can perform drain detection and/or calibrate orrecalibrate the sensors based on detection of drain, infusion, andlikewise. Additionally, the user can manually instruct the controller ofthe ostomy device to calibrate the sensors by pressing the calibrationbutton 2204, and/or inform the controller that the bag is empty bypressing the drain button 2206.

The user device can pair to the sensor device under the pretense thatthe device is the master and the sensor is the slave. The device maysend specific UUID's to the sensor to be able to read its data. This maybe done after the device pairs to the sensor. When the user disconnectsfrom the device, the application may call the DisconnectPeripheralmethod from CoreBluetooth or the native library. This can handledisconnection as well as unpairing the device. If the sensor devicecomes out of range with the user device, it may disconnect but notunpair. Once the device is back in range, the device may repair with thesensor. This is accomplished using the following method from theCoreBluetooth or native library framework.

FIG. 23 shows an example alarm user interface 2300. In this example,there is an alarm volume slider 2302, a vibration mode toggle 2304, anda red toggle 2306, and an orange toggle 2308. Users can set alarms fordifferent fill levels of the bag. When each measurement is taken andrecorded, the application may check whether the measurement shouldtrigger any of the current alarms. If measurement should trigger one ormore alarms, the application may present notification(s) to the userthat one of their alarms has been triggered. Additional alarm featurescould include alerts to manually check the bag, to replace reusablehubs, to remind a user to not be in a supine position, and the like.

The application may also have an additional feedback feature. Forexample, the additional feedback feature may be called the “AlfredConnect.” This feature provides additional feedback to the user. Thisfeature may use the same functionality above. The additional feedbackfeature can have multiple Bluetooth sensors connected to multiplepatients at once. This can be achieved by assigning each patient andsensor a unique ID for pairing. FIG. 24 shows an example user interfaceof an additional hydration tracker 2400 feedback feature. The examplehydration tracker 2400 has a daily hydration goal counter 2402, a watertracker 2404, a caffeine beverage tracker 2406, an alcoholic beveragetracker 2408, and another beverage tracker 2410. Additional types ofliquid intakes could also be used such as soup, soda, sports drinks, andetc. FIG. 25 show a user interface of an example hydration progressscreen 2500. The example hydration progress screen 2500 shows whether auser's hydration goal is met. The example screen 2500 can display one ormore bar graphs 2502 to track different types of liquid intake the userhas ingested. The hydration summary can be retrieved by using an APIthat fetches the user's hydration data from the backend server. The dataretrieval can be from a selected date, which can be displayed at the topof the screen, to a current date. The hydration feature can also be usedin tandem with the alarm page 2300 to remind the user to intake liquidthroughout the day or notify when the user needs to ingest more liquidor electrolytes.

FIG. 26A shows an example of an additional user interface of a restroomlocator 2600. This feature shows the nearest restrooms for the user sohe or she may empty the ostomy bag. The user interface of theapplication can display a map 2602. The map 2602 showing the nearestrestrooms 2604 may also provide directions, such as with a “GO” button2608 or a button with similar instructions. When the user taps the “GO”button 2604 or tap on one of the locations 2610 in the table view, theuser can be directed to the maps app with the restroom location set astheir desired destination. The restroom locator can work as follows: 1)the backend server can contain a data table with all the restroomlocations and/or their coordinates and cross streets. 2) The appretrieves a set amount of restroom locations based on the desired radiusof the user. This is achieved through an API that returns restroomlocations based on the radius and coordinates of the user. 3) Thedistance between the user's location and each restroom is calculatedusing an algorithm function.

FIGS. 26B-26C show example user interfaces 2360, 2640 displaying bothestimated stoma output 2632 and restroom location 2634. The user cantoggle between an animated graphic indicator displaying output 2636(FIG. 26B) and an animated graphic indicator displaying distance to anearby restroom 2638 (FIG. 26C). The animated graphic indicator foroutput 2636 can include a circle with a changing fill level 2637 tovisually inform the user about an estimate volume of the bag. The usercan tap an information icon 2633 in FIG. 26B to be directed to an outputmeasurement user interface 2650, such as shown in FIG. 26D, to obtainmore information relating to the output. The distance value in theanimated graphic indicator for distance to a restroom 2638 can change asthe user moves toward or away from the target restroom. The user canalso click the location icon 2635 to be taken to a map interface, suchas shown in FIG. 26A. The user interfaces also can include other icons,such as “Status” 2642 for checking the state of the connected ostomybag, “Care” 2644 for connecting with a medical professional, “Inbox”2646 for connecting with the ostomy bag user community, and/or “Profile”2648 to set up a user profile. A user may be able to change the bag sizeby accessing “Profile.” The name of these icons are provided as examplesand are not limiting. Other icons can be included in the user interface.The user interface examples in FIGS. 26B-26C can also optionally includea hydration tracker so that the application can provide tracking of theoutput, the restroom locator, and the hydration status, such asexplained in an application overview display page 2660 shown in FIG.26E.

Each of the example user interfaces shown can include one or more userinterface controls that can be selected by a user, for example, using abrowser or other application software (such as a mobile application).Thus, each of the user interfaces shown may be output for presentationby electronic hardware as graphical user interfaces, which mayoptionally include a browser or any other application software installedthereon that outputs the user interfaces.

The user interface controls shown are merely illustrative examples andcan be varied. For instance, any of the user interface controls shownmay be substituted with other types of user interface controls thatprovide the same or similar functionality. Some examples of userinterface controls that may be used include buttons, dropdown boxes,select boxes, text boxes or text fields, checkboxes, radio buttons,toggles, breadcrumbs (e.g., identifying a page or interface that isdisplayed), sliders, search fields, pagination controls, tags, icons,tooltips, progress bars, notifications, message boxes, image carousels,modal windows (such as pop-ups), date and/or time pickers, accordions(e.g., a vertically stacked list with show/hide functionality), and thelike. Additional user interface controls not listed here may be used.

Further, user interface controls may be combined or divided into othersets of user interface controls such that similar functionality or thesame functionality may be provided with very different looking userinterfaces. Moreover, each of the user interface controls may beselected by a user using one or more input options, such as a mouse,touch screen input (e.g., finger or pen), or keyboard input, among otheruser interface input options. Although each of these user interfaces areshown implemented in a mobile device, the user interfaces or similaruser interfaces can be output by any computing device, examples of whichare described above.

Thermal Imaging Examples

As described above (for example, with respect to FIGS. 1 and 2), thetemperature sensors in the ostomy wafer and/or the ostomy bag can beinfrared (IR) temperature sensors, which may be thermal imaging sensorsor infrared thermometers. IR temperature sensors can provide temperatureoutputs similar to the thermistors described above. Thus, any of thealgorithms described herein for analyzing temperature output fromthermistors or other temperature sensors can apply to IR temperaturesensors. Thermal imaging using IR temperature sensors, for instance, hasa potential advantage over thermistors in that no contact may berequired to measure temperature with a thermal imaging sensor. Thus, ifan ostomy wafer peels away from the skin, an IR temperature sensor inthe ostomy wafer may still be able to detect temperature of the skin.

Example output of IR temperature sensors can be conceptualized byanalyzing the example output of a test thermal imaging camera, as shownin FIGS. 27-32. In FIG. 27, a test setup 2700 of an ostomy bag 2720using a thermal imaging camera 2730 is shown. The ostomy bag 2720 isshown attached to a dummy 2722, which can be filled from the back (notshown) with food or liquid to cause that food or liquid to enter theostomy bag 2720. The thermal imaging camera 2730 takes a thermal imageof the ostomy bag 2720 to identify temperature changes in the bag asfood or liquid enters the bag and as that food or liquid remains in thebag over time. The test setup 2700 shown can be used to validate the useof temperature sensors in an ostomy bag.

FIG. 28 depicts an example thermal image 2800 of a patient's stoma 2810.The thermal image 2800 may have been taken using a camera such as thecamera 2730. The thermal image 2800 provides an indication of exampletemperatures at and around a stoma.

FIGS. 29-31 depict example thermal images of the ostomy bag 2720 of FIG.27. In FIG. 29, images 2910-2940 depict an apple sauce infusion. Inimage 2910, the image depicts material currently in the bag. The image1920 depicts image during an infusion of apple sauce. The image 1930depicts the bag immediately after the infusion. The final image, 1940,depicts the bag five minutes after the infusion. FIGS. 30 and 31 depictsimilar images 3010-3040 and 3110-3140 for oatmeal and mashed potatoes,respectively.

The ostomy wafer or the ostomy bag can include one or more IRtemperature sensors. A plurality of IR temperature sensors can bedispersed about the ostomy wafer or the ostomy bag. These sensors wouldbe generally far closer to the patient's skin than the thermal imagingcamera 2730 of FIG. 27. Accordingly, the images or temperatures outputby each sensor in the wafer and/or the bag may individually depict justa portion of the temperature at the wafer and/or the bag. Collectively,a plurality of IR temperature sensors can provide temperature data for alarge area of the wafer and/or bag.

The hub 122 can poll the IR temperature sensors periodically, such asevery second, every minute, every five minutes, or at some otherinterval. The outputs from these sensors can be provided to a processor,which can average or otherwise combine the images or temperatures into asingle image for further analysis. The processor could also analyze theimages or temperatures separately without combining them together. Theprocessor can be in the hub 122, user device 130, or the backend system170 (which may be in the cloud). The processor can use any of the leakdetection, irritation detection, bag fill, or other algorithms describedherein to analyze the output of the IR temperature sensors.

Additional Example Combinations of Features

In some configurations, a system for detecting skin inflammation caninclude a flexible sheet, having an adhesive on at least a first surfacefor adhering to skin; a plurality of temperature sensors in a firstregion of the flexible sheet for measuring the temperature in the firstregion of the flexible sheet; at least one temperature sensor in asecond region of the flexible sheet for measuring the temperature in thesecond region of the flexible sheet, the second region being remote fromthe first region; a wireless transmitter configured to transmit dataderived from the temperature sensors to a wireless receiver; and acomparator adapted to compare the temperature in the first region of theflexible sheet with the temperature in the second region of the flexiblesheet, and thereby produce a difference signal indicative of thepresence or absence of skin inflammation in a region of skin in contactwith the first region of the flexible sheet.

In one configuration, the system can further include a wireless receiverfor receiving the signal transmitted by the wireless transmitter andcommunicating the detected presence or absence of skin inflammation to auser.

In one configuration, the wireless receiver can include a visual displayfor presenting to the user a visual representation of the difference intemperature between the first region of the flexible sheet and thesecond region of the flexible sheet.

In one configuration, the wireless receiver can include an alarm foralerting the user when the detected difference in temperature betweenthe first region of the flexible sheet and the second region of theflexible sheet exceeds a preselected threshold.

In some configurations, the data transmitted from the wirelesstransmitter to the wireless receiver can be data indicative of thecomparison of the temperature in the first region of the flexible sheetwith the temperature in the second region of the flexible sheet, and thecomparator is mounted on or proximate to the flexible sheet.

In some configurations, the data transmitted from the wirelesstransmitter to the wireless receiver can be data indicative of thetemperature in the first region of the flexible sheet and thetemperature in the second region of the flexible sheet, and thecomparator is incorporated in the wireless receiver.

In some configurations, a system for detecting skin inflammation caninclude a flexible sheet, having an adhesive on at least a first surfacefor adhering to skin; a plurality of temperature sensors in a firstregion of the flexible sheet for measuring the temperature in the firstregion of the flexible sheet; at least one temperature sensor in asecond region of the flexible sheet for measuring the temperature in thesecond region of the flexible sheet, the second region being remote fromthe first region; an electrical connector to enable connection of aprocessor to the temperature sensors, wherein each said temperaturesensor can be connected to the electrical connector by at least oneelectrical conductor; and a pattern of indicia defining at least oneseverance region, such that severing the flexible sheet in the severanceregion enables the removal of a part of the flexible sheet, togetherwith one or more of the temperature sensors, thereby creating an openingin the flexible sheet, such that any said electrical conductors whichare connected to temperature sensors which are not thereby removed canremain intact after the severance process.

In some configurations, the severance region can include a plurality ofconcentric circles or partial circles, such that severing the flexiblesheet at each said concentric circle or partial circle provides acircular opening of a different size.

In some configurations, the system can include a processor connected tothe electrical connector for obtaining the temperature values reportedby each said temperature sensor.

In some configurations, the system can include a wireless transmitterconfigured to transmit data derived from the temperature sensors to awireless receiver.

In some configurations, the system can include a wireless receiver forreceiving the signal transmitted by the wireless transmitter andcommunicating the data derived from the temperature sensors to a user.

In some configurations, the wireless receiver includes a visual displayfor presenting to the user a visual representation of the difference intemperature between the first region of the flexible sheet and thesecond region of the flexible sheet.

In some configurations, the wireless receiver includes an alarm foralerting the user when the detected difference in temperature betweenthe first region of the flexible sheet and the second region of theflexible sheet exceeds a preselected threshold.

In some configurations, the system can include a comparator adapted tocompare the temperature in the first region of the flexible sheet withthe temperature in the second region of the flexible sheet, and therebyproduce a difference signal indicative of the presence or absence ofskin inflammation in a region of skin in contact with the first regionof the flexible sheet.

In some configurations, the system can include a wireless transmitter,wherein the data transmitted from the wireless transmitter to thewireless receiver is data indicative of the comparison of thetemperature in the first region of the flexible sheet with thetemperature in the second region of the flexible sheet, and thecomparator is mounted on or proximate to the flexible sheet.

In some configurations, the system can include a wireless transmitterand a wireless receiver, wherein the data transmitted from the wirelesstransmitter to the wireless receiver can be data indicative of thetemperature in the first region of the flexible sheet and thetemperature in the second region of the flexible sheet, and thecomparator can be incorporated in the wireless receiver.

In some configurations, the temperature sensors can be positioned in theflexible sheet such that when the device is applied to a wound on theskin surface, the plurality of temperature sensors in the first regionof the flexible sheet detect the temperature of skin adjacent to thewound and the at least one temperature sensor in the second region ofthe flexible sheet detects the temperature of skin remote from the wound

In some configurations, the flexible sheet can form part of an ostomywafer and is dimensioned so as to be positioned around a colostomystoma, an ileostomy stoma or a urostomy stoma.

In some configurations, the temperature sensors can be thermistors or IRtemperature sensors.

In some configurations, an ostomy system for detecting peristomal skininflammation can include an ostomy wafer comprising a flexible sheet,having an adhesive on at least a first surface for adhering to skin; aplurality of temperature sensors in the peristomal region of the ostomywafer for measuring the temperature in the peristomal region of theostomy wafer; at least one temperature sensor in a second region of theostomy wafer for measuring the temperature in the second region of theostomy wafer, the second region being remote from the peristomal region;and an electrical connector to enable connection of a processor to thetemperature sensors, wherein each said temperature sensor can beconnected to the electrical connector by at least one electricalconductor; and an ostomy bag having means for receiving a wirelesstransmitter configured to transmit data derived from the temperaturesensors to a wireless receiver.

In some configurations, the system can include a processor connected tothe electrical connector for obtaining the temperature values reportedby each said temperature sensor.

In some configurations, the system can include a wireless transmittermounted on the ostomy bag and configured to transmit data derived fromthe temperature sensors to a wireless receiver.

In some configurations, the system can include a wireless receiver forreceiving the signal transmitted by the wireless transmitter andcommunicating the data derived from the temperature sensors to a user.

In some configurations, the wireless receiver can include a visualdisplay for presenting to the user a visual representation of thedifference in temperature between the peristomal region of the ostomywafer and the second region of the ostomy wafer.

In some configurations, the wireless receiver includes an alarm foralerting the user when the detected difference in temperature betweenthe peristomal region of the ostomy wafer and the second region of theostomy wafer exceeds a preselected threshold.

In some configurations, the system can include a comparator adapted tocompare the temperature in the peristomal region of the ostomy waferwith the temperature in the second region of the ostomy wafer, andthereby produce a difference signal indicative of the presence orabsence of skin inflammation in the peristomal skin.

In some configurations, the system can include a wireless transmitter,wherein the data transmitted from the wireless transmitter to thewireless receiver can be data indicative of the comparison of thetemperature in the peristomal region of the ostomy wafer with thetemperature in the second region of the ostomy wafer, and the comparatoris mounted on or proximate to the flexible sheet.

In some configurations, the system can include a wireless transmitterand a wireless receiver, wherein the data transmitted from the wirelessreceiver to the wireless receiver can be data indicative of thetemperature in the peristomal region of the ostomy wafer and thetemperature in the second region of the ostomy wafer, and the comparatoris incorporated in the wireless receiver.

In some configurations, the system can include a pattern of indiciadefining at least one severance region, such that severing the ostomywafer in the severance region can enable the removal of a part of theostomy wafer, together with one or more of the temperature sensors,thereby creating an opening in the ostomy wafer, such that any saidelectrical conductors which are connected to temperature sensors whichare not thereby removed remain intact after the severance process.

In some configurations, the severance region can include a plurality ofconcentric circles or partial circles, such that severing the ostomywafer at each said concentric circle or partial circle provides acircular opening of a different size.

In some configurations, A method for detecting skin inflammation caninclude adhering a flexible sheet to the skin, the flexible sheet havinga plurality of temperature sensors in a first region for measuring thetemperature in the first region of the flexible sheet and at least onetemperature sensor in a second region of the flexible sheet formeasuring the temperature in the second region of the flexible sheet,the second region being remote from the first region; measuring thetemperature in the first region and the second region of the flexiblesheet; and comparing the temperature in the first region of the flexiblesheet with the temperature in the second region of the flexible sheet,thereby detecting the presence or absence of skin inflammation in aregion of skin in contact with the first region of the flexible sheet.

In some configurations, an ostomy bag can include two walls joinedtogether along a seam around at least a portion of an edge of the ostomybag, a first one of the walls configured to be placed facing skin of auser and a second one of the walls configured to face away from the userwhen the first wall faces the skin of the user; an opening in the firstwall, the opening configured to be disposed around a stoma of the userand to receive effluent from the stoma; and a plurality of temperaturesensors and a plurality of capacitive sensors, wherein the plurality oftemperature sensors measure a temperature change due to the effluententering the bag, and wherein the plurality of capacitive sensorsmeasure a capacitance change due to the effluent entering the bag, thesensor layer further comprising one or more wireless communicationantennas, wherein when in use, the one or more antennas are inelectrical communication with one or more antennas on an ostomy waferconfigured to couple the first one of the walls of the ostomy bag to theskin of the user, and/or one or more antennas on a hub configured to becoupled to the ostomy bag on the second one of the walls.

In some configurations, the plurality of temperature sensors and theplurality of capacitive sensors are located on a sensor layer disposedin, on, or between one of the two walls of the ostomy bag.

In some configurations, the plurality of temperature sensors and theplurality of capacitive sensors are printed on one or both of the twowalls of the ostomy bag.

In some configurations, the capacitive sensors are arranged in a patternof lines at non-90 degree angles with respect to one another.

In some configurations, the capacitive sensors are configured to detecta fill level of the effluent in the bag when the bag is in an uprightposition and tilted.

In some configurations, an ostomy bag can include two walls joinedtogether along a seam around at least a portion of an edge of the ostomybag, a first one of the walls configured to be placed facing skin of auser and a second one of the walls configured to face away from the userwhen the first wall faces the skin of the user; an opening in the firstwall, the opening configured to be disposed around a stoma of the userand to receive effluent from the stoma; and a sensor layer disposed in,on, or between one of the two walls of the ostomy bag, the sensor layercomprising a plurality of temperature sensors and a plurality ofcapacitive sensors, wherein the plurality of temperature sensors measurea temperature change due to the effluent entering the bag, and whereinthe plurality of capacitive sensors measure a capacitance change due tothe effluent entering the bag, the sensor layer further comprising oneor more wireless communication antennas, wherein when in use, the one ormore antennas are in electrical communication with one or more antennason an ostomy wafer configured to couple the first one of the walls ofthe ostomy bag to the skin of the user, and/or one or more antennas on ahub configured to be coupled to the ostomy bag on the second one of thewalls.

In some configurations, the capacitive sensors can be arranged in apattern of lines at non-90 degree angles with respect to one another.

In some configurations, an ostomy bag can include two walls joinedtogether along a seam around at least a portion of an edge of the ostomybag, a first one of the walls configured to be placed facing skin of auser and a second one of the walls configured to face away from the userwhen the first wall faces the skin of the user; an opening in the firstwall, the opening configured to be disposed around a stoma of the userand to receive effluent from the stoma; and a sensor layer disposed inone of the two walls of the ostomy bag, the sensor layer comprisingtemperature sensors configured to measure temperature of the effluent.

In some configurations, a method of detecting skin irritation around astoma can include under control of a hardware processor, sensingtemperature readings of a plurality of temperature sensors disposed in aring about an ostomy wafer; detecting a slow change in the temperatureof one or more of the temperature sensors, the rapid slow changeoccurring greater than a threshold time; and outputting an indicatingthat irritation has occurred at a location in the ostomy wafercorresponding with the one or more temperature sensors.

In some configurations, the method can be implemented with any of thefeatures of an ostomy device disclosed herein.

In some configurations, a method of detecting fill of an ostomy bag caninclude under control of a hardware processor, sensing temperature withreadings of a plurality of temperature sensors disposed in an ostomybag; detecting a change in the temperature of a plurality of thetemperature sensors as a flow; and outputting an indicating that avolume of bag fill has increased responsive to detecting the change inthe temperature.

In some configurations, the plurality of temperature sensors aredisposed in a matrix in the ostomy bag.

In some configurations, the hardware processor can be configured todetect the change in temperature as a change in temperature progressingfrom first ones of the temperature sensors at an upper part of theostomy bag and to second ones of the temperature sensors at a lower partof the ostomy bag.

In some configurations, the hardware processor is further configured todetect a phase of the effluent based on a speed of the change intemperature.

In some configurations, the hardware processor is further configured toconsider the temperature change to correspond to effluent but to rejecta second temperature change that does not correspond to temperaturechanges flowing from the first temperature sensors to the secondtemperature sensors.

In some configurations, the hardware processor is further configured toreject a second temperature change that is below a threshold rate.

In some configurations, the hardware processor is further configured tocalibrate based on detecting body temperature prior to flow of theeffluent.

In some configurations, the hardware processor is further configured tocause temperature changes to be ignored that are due to gas.

In some configurations, the hardware processor is further configured tosubtract a volume of effluent due to gas from a volume calculation basedon the fill detection.

In some configurations, the hardware processor is further configured todetect the gas based on output from a gas sensor disposed in the ostomybag.

In some configurations, the method can include causing to be displayedon a user device in electrical communication with the bag a volume ofbag fill.

In some configurations, the method can include causing to be displayedon a user device in electrical communication with the bag a distance toa nearby restroom.

In some configurations, the method can include causing to be displayedon a user device in electrical communication with the bag a hydrationtracker.

In some configurations, the method can be implemented with any of thefeatures of an ostomy device disclosed herein.

In some configurations, a method of detecting phasing of effluent in anostomy bag can include under control of a hardware processor, sensingtemperature values of a plurality of temperature sensors disposed in anostomy bag, the plurality of temperature sensors being in contact withthe output; and determining a phase of the effluent based in part on thetemperature values.

In some configurations, the detecting is based in part on a rate ofchange of the temperature values of the plurality of temperature sensorsin contact with the effluent.

In some configurations, the detecting is based in part on a flow ratedetermined from the temperature values of the plurality of temperaturesensors.

In some configurations, the temperature values are presented as a heatmap.

In some configurations, a heavier thermal print on the heat mapindicates a more viscous effluent.

In some configurations, the calculating is performed by machinelearning.

In some configurations, the calculating is performed by a trained neuralnetwork model.

In some configurations, the trained neural network model is configuredto recognize borders between effluents of different phases on the heatmap.

In some configurations, a system for monitoring an ostomy patient caninclude a wireless device configured to receive sensor signals from anostomy device, the sensor signals comprising signals related totemperature; a memory device storing processor-executable instructions;a hardware processor configured to execute the processor-executableinstructions to perform any of the features of using the ostomy devicedisclosed herein or optionally to provide the sensor signals to abackend server that performs any of the features of using the ostomydevice disclosed herein; and a display configured to output a result ofexecution of the processor-executable instructions, the resultcomprising one or more of: an indication of a leak, an indication ofskin irritation, and an indication of volume of effluent in the ostomydevice.

In some configurations, the hardware processor can be further configuredto output one or more of the following: a user interface comprisingfunctionality for a user to specify hydration and/or food input, a userinterface configured to output information related to the specifiedhydration and/or food input, a user interface configured to alert theuser to a need to obtain more hydration and/or food input, a userinterface configured to indicate a nearby restroom location, and a userinterface configured to indicate that hydration and/or food input isavailable at the restroom location.

Terminology

Many other variations than those described herein will be apparent fromthis disclosure. For example, depending on the embodiment, certain acts,events, or functions of any of the algorithms described herein can beperformed in a different sequence, can be added, merged, or left outaltogether (for example, not all described acts or events are necessaryfor the practice of the algorithms). Moreover, in certain embodiments,acts or events can be performed concurrently, for example, throughmulti-threaded processing, interrupt processing, or multiple processorsor processor cores or on other parallel architectures, rather thansequentially. In addition, different tasks or processes can be performedby different machines and/or computing systems that can functiontogether.

The various illustrative logical blocks, modules, and algorithm stepsdescribed in connection with the embodiments disclosed herein can beimplemented as electronic hardware, computer software, or combinationsof both. To clearly illustrate this interchangeability of hardware andsoftware, various illustrative components, blocks, modules, and stepshave been described above generally in terms of their functionality.Whether such functionality is implemented as hardware or softwaredepends upon the particular application and design constraints imposedon the overall system. The described functionality can be implemented invarying ways for each particular application, but such implementationdecisions should not be interpreted as causing a departure from thescope of the disclosure.

The various illustrative logical blocks and modules described inconnection with the embodiments disclosed herein can be implemented orperformed by a machine, such as a hardware processor comprising digitallogic circuitry, a general purpose processor, a digital signal processor(DSP), an application specific integrated circuit (ASIC), a fieldprogrammable gate array (FPGA) or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described herein.A general purpose processor can be a microprocessor, but in thealternative, the processor can be a controller, microcontroller, orstate machine, combinations of the same, or the like. A processor caninclude electrical circuitry configured to process computer-executableinstructions. In another embodiment, a processor includes an FPGA orother programmable device that performs logic operations withoutprocessing computer-executable instructions. A processor can also beimplemented as a combination of computing devices, for example, acombination of a DSP and a microprocessor, a plurality ofmicroprocessors, one or more microprocessors in conjunction with a DSPcore, or any other such configuration. A computing environment caninclude any type of computer system, including, but not limited to, acomputer system based on a microprocessor, a mainframe computer, adigital signal processor, a portable computing device, a devicecontroller, or a computational engine within an appliance, to name afew.

The steps of a method, process, or algorithm described in connectionwith the embodiments disclosed herein can be embodied directly inhardware, in a software module stored in one or more memory devices andexecuted by one or more processors, or in a combination of the two. Asoftware module can reside in RAM memory, flash memory, ROM memory,EPROM memory, EEPROM memory, registers, hard disk, a removable disk, aCD-ROM, or any other form of non-transitory computer-readable storagemedium, media, or physical computer storage known in the art. An examplestorage medium can be coupled to the processor such that the processorcan read information from, and write information to, the storage medium.In the alternative, the storage medium can be integral to the processor.The storage medium can be volatile or nonvolatile. The processor and thestorage medium can reside in an ASIC.

Conditional language used herein, such as, among others, “can,” “might,”“may,” “for example,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isgenerally intended to convey that certain embodiments include, whileother embodiments do not include, certain features, elements and/orstates. Thus, such conditional language is not generally intended toimply that features, elements and/or states are in any way required forone or more embodiments or that one or more embodiments necessarilyinclude logic for deciding, with or without author input or prompting,whether these features, elements and/or states are included or are to beperformed in any particular embodiment. The terms “comprising,”“including,” “having,” and the like are synonymous and are usedinclusively, in an open-ended fashion, and do not exclude additionalelements, features, acts, operations, and so forth. Also, the term “or”is used in its inclusive sense (and not in its exclusive sense) so thatwhen used, for example, to connect a list of elements, the term “or”means one, some, or all of the elements in the list. Further, the term“each,” as used herein, in addition to having its ordinary meaning, canmean any subset of a set of elements to which the term “each” isapplied.

Disjunctive language such as the phrase “at least one of X, Y and Z,”unless specifically stated otherwise, is to be understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z, or a combination thereof. Thus, such conjunctivelanguage is not generally intended to imply that certain embodimentsrequire at least one of X, at least one of Y and at least one of Z toeach be present.

Unless otherwise explicitly stated, articles such as “a” or “an” shouldgenerally be interpreted to include one or more described items.Accordingly, phrases such as “a device configured to” are intended toinclude one or more recited devices. Such one or more recited devicescan also be collectively configured to carry out the stated recitations.For example, “a processor configured to carry out recitations A, B andC” can include a first processor configured to carry out recitation Aworking in conjunction with a second processor configured to carry outrecitations B and C.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the devices or algorithms illustrated can be madewithout departing from the spirit of the disclosure. As will berecognized, certain embodiments of the inventions described herein canbe embodied within a form that does not provide all of the features andbenefits set forth herein, as some features can be used or practicedseparately from others.

What is claimed is:
 1. An ostomy wafer configured to be coupled to anostomy bag, the ostomy wafer comprising: an adhesive layer configured toadhere to skin around a stoma of a living person; a flexible sensorlayer coupled with the adhesive layer, the flexible sensor layercomprising a plurality of temperature sensors; and a plurality ofconductors wired to the plurality of temperature sensors, the pluralityof conductors configured to be electrically coupled with a processorlocated at or proximate to the ostomy bag so that signals from theplurality of temperature sensors are electrically communicated to theprocessor, wherein the flexible sensor layer comprises a neck and abody, the plurality of conductors being disposed in part on the neck. 2.The ostomy wafer of claim 1, wherein the ostomy wafer further comprisesa third layer configured to cover the flexible sensor layer such thatthe flexible sensor layer is sandwiched between the adhesive layer andthe third layer.
 3. The ostomy wafer of claim 2, wherein the third layercomprises an adhesive configured to adhere to an ostomy bag.
 4. Theostomy wafer of claim 1, wherein the temperature sensors are arranged inconcentric rings or concentric partial rings.
 5. The ostomy wafer ofclaim 4, wherein one or more of the concentric partial rings areseverable so as to fit the ostomy wafer to different sized stomas. 6.The ostomy wafer of claim 4, wherein the concentric partial ringscomprise two or more rings.
 7. The ostomy wafer of claim 1, wherein theplurality of conductors comprise curved portions between the temperaturesensors.
 8. The ostomy wafer of claim 1, wherein the plurality oftemperature sensors are electrically connected in a matrix circuit. 9.The ostomy wafer of claim 1, further comprising one or more capacitivesensors.
 10. The ostomy wafer of claim 9, wherein the one or morecapacitive sensors are disposed on the flexible sensor layer or a secondflexible sensor layer.
 11. The ostomy wafer of claim 9, wherein the oneor more capacitive sensors are configured to detect moisture inadhesives of the adhesive layer.
 12. The ostomy wafer of claim 1,wherein a first temperature sensor of the plurality of temperaturesensors is disposed on the neck as a reference sensor.
 13. The ostomywafer of claim 12, wherein all other ones of the temperature sensorsother than the first temperature sensor are disposed on the body. 14.The ostomy wafer of claim 1, wherein the temperature sensors comprisefirst temperature sensors disposed in a first region closer to a centerof the body and second temperature sensors disposed in a second regionfarther from the center of the body.
 15. The ostomy wafer of claim 14,wherein the second temperature sensors are used as reference temperaturesensors.
 16. The ostomy wafer of claim 1, wherein the adhesive layercomprises hydrocolloid adhesives.
 17. The ostomy wafer of claim 1,further comprising a border ring surrounding the adhesive layer, theborder ring comprising an adhesive side configured to adhere to the skinaround the stoma.
 18. The ostomy wafer of claim 17, wherein the adhesiveside of the border ring comprises acrylic adhesives or hydrocolloidadhesives.
 19. The ostomy wafer of claim 1, further comprising a printedcircuit board (PCB) in electrical communication with the plurality oftemperature sensors, the PCB configured to send the signals from theplurality of temperature sensors to the processor located at orproximate to the ostomy bag.
 20. The ostomy wafer of claim 1, incombination with an ostomy bag comprising a plurality of sensors. 21.The ostomy wafer of claim 1, further comprising at least one antennaring for wireless communication with the processor located at orproximate to the ostomy bag, the at least one antenna ring comprisesconductive traces.
 22. The ostomy wafer of claim 21, wherein the atleast one antenna ring is concentric with and located radially outwardfrom the plurality of conductors, wherein the plurality of conductorscomprise concentric rings.
 23. The ostomy wafer of claim 21, wherein theat least one antenna ring and the plurality of conductors cross at oneor more locations.